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Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.
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A Study of R-ICE and Lenalidomide for Treating Patients with First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Effectiveness of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics, and preliminary effectiveness of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
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Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™
Rochester, MN
The purpose of this study is to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used to assess radiographic response at the end of treatment. Each subject's treatment assignment will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years.
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Rochester, MN
The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT
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Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Rochester, MN
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with ...
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A Study to Evaluate Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...
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Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Rochester, MN
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.
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Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma
Rochester, MN
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL)
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Combination Chemotherapy or 90-Yttrium Ibritumomab Tiuxetan and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Relapsed Diffuse Large B-cell Non-Hodgkin Lymphoma
No Locations
This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination chemotherapy compared with combination chemotherapy alone before stem cell transplant in treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a period of improvement. Radioactive substances linked to monoclonal antibodies, such as 90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by ...
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A Study of the Effectiveness and Safety of CTL019 in Adult Patients with Diffuse Large B-Cell Lymphoma
No Locations
The purpose of this study is to determine the efficacy and safety of CTL019 in adult patients with relapsed or resistant diffuse large B-cell lymphoma.
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Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Rochester, MN
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a ...
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GEN3013, Epcoritamab Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™ NHL-1
Scottsdale/Phoenix, AZ
The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.
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A Study to Assess the Safety and Preliminary Effectiveness of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this study is to evaluate the safety and preliminary effectiveness of the human anti-CD19 antibody Tafasitamab, in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
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A Study to Compare Tisagenlecleucel vs. Standard of Care in Adult Patients with Aggressive B-cell Non-Hodgkin Lymphoma
Jacksonville, FL
This is a randomized, open label, multicenter phase III trial to determine the efficacy and safety of tisagenlecleucel treatment strategy in adult patients with relapsed or refractory aggressive B-cell NHL after failure of rituximab and anthracycline containing frontline immunochemotherapy.
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A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
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A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma
Rochester, MN
This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumab in combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation therapy in previously untreated subjects with high-risk DLBCL. Patients with non-ABC subtype (determined by gene expression profiling) will be allocated to Arm A while patients with ABC (activated B-cell type) subtype will be allocated to Arm B. Approximately 120 patients may be enrolled and assigned into the appropriate treatment arms dependent upon their cell of origin status. Induction treatment with R-CHOP (± Lenalidomide) will last ...
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Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Jacksonville, FL; Rochester, MN
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and INCB039110, a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with INCB039110 in subjects with relapsed/refractory B-cell malignancies.
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A Study to Evaluate the Safety and Effectiveness of Axicabtagene Ciloleucel in Combination with Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)
Jacksonville, FL; Rochester, MN
The primary objective of this study is to estimate the safety and effectiveness of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Rochester, MN
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells ...
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Exploring Mechanisms of Action and Resistance of Therapeutic Agents in Patients with B-cell Malignancies
Jacksonville, FL
This study is being performed to understand the causes of drug resistance and to improve the treatment options for patients diagnosed with B-cell cancers. We aim to identify the reasons why certain therapies work and others don’t and as result- develop new treatments for blood cancers.
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Study to Evaluate the Safety and Effectiveness of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Relapsed/Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward from Phase 1 into Phase 2, and to evaluate the effectiveness of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma in Phase 2.
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Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia (CLOVER-WaM)
Jacksonville, FL
This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard therapy for their underlying malignancy.
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A Study of Tyrosine Kinase Inhibitor ICP-022 in Patients With r/r B-Cell Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
The main purpose of this study is to assess the maximal dose of ICP-022 that can be safely administered.
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Study Treating Patients with Relapsed or Refractory Aggressive B-cell Lymphomas Using Nivolumab with or without Varlilumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating the immune system to attack cancer tumor cells.
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A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML
Rochester, MN
The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory AML after treatment with standard therapy.
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A Study of TAK-981 in Combination with Rituximab in Participants with Relapsed/Refractory (r/r) CD20-positive (CD20+) Non-Hodgkin Lymphoma (NHL)
Rochester, MN
The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with rituximab in participants with r/r CD20+ NHL in Phase 1b, and to evaluate the effectiveness of TAK-981 in combination with rituximab in r/r CD20+ NHL in Phase 2.
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Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Rochester, MN; Rochester, MN
Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
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Study of BMF-219, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), and Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.
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Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
Rochester, MN
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 (AMP-514) in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy. The primary objectives are to determine the maximum tolerated dose (MTD) or highest protocol-defined dose (HPDD); in the absence of exceeding the MTD of MEDI-551 in combination with MEDI0680 (AMP-514); and to evaluate the safety, tolerability, and clinical activity of MEDI-551 in combination with MEDI0680 (AMP-514).
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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies (MorningSun)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).
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Ruxolitinib Phosphate (Oral JAK Inhibitor INCB18424) in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well giving ruxolitinib phosphate (oral JAK inhibitor INCB18424) works in treating patients with relapsed or refractory diffuse large B-cell or peripheral T-cell non-hodgkin lymphoma and are ineligible to stem cell transplant or have recurrent disease after stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Rochester, MN
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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A Clinical Study Using MEDI-551 in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
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Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to see if giving lenzilumab prior to axicabtagene ciloleucel will reduce the neurologic side effects of axicabtagene ciloleucel when used to treat lymphoma.
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A Study Evaluating the Effectiveness and Safety of Axicabtagene Ciloleucel in Subjects with High-Risk Large B-Cell Lymphoma
Rochester, MN
The purpose of this study is to to estimate the effectiveness of axicabtagene ciloleucel, as measured by complete response (CR) rate, in subjects with high-risk large B-cell lymphoma.
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Axicabtagene Ciloleucel Expanded Access Study
Rochester, MN
A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.
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Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
Rochester, MN
This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL).
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A Study Evaluating the Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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An Effectiveness and Safety Study of Daratumumab in Relapsed/Resistant Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess overall response rate, including complete and partial response, of daratumumab in patients with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
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A Study to Evaluate CTX110 in Subjects with Relapsed or Refractory B-Cell Malignancies
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness CTX110 in subjects with relapsed or refractory B cell malignancies.
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A Study of Copanlisib and Nivolumab in Treating Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate how well copanlisib and nivolumab work in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
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A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
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A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Study to Assess the Effectiveness and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone to Treat Patients with Previously Treated Non-Hodgkins Lymphoma
Jacksonville, FL
The purpose of this study is to evaluate the efficacy and safety of TGR-1202 both alone and in combination with ublituximab in the treatment of previously treated Diffuse Large B‐Cell Lymphoma patients.
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A Safety and Effectiveness Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta®.
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Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: ...
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A Study to Compare the Effectiveness and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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A Phase 1b/2 Safety and Tolerability of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Scottsdale/Phoenix, AZ
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL. MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.
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A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies
Rochester, MN
This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.
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Phase I Dose Escalation Study for BAY 1251152 in Patients With Advanced Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
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DALY 2.0 USA/ MB-CART2019.1 for DLBCL
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the effectiveness of MB-CART2019.1 cells administered following a conditioning lymphodepletion regimen in diffuse large B cell lymphoma (DLBCL) subjects who failed at least two lines of therapy as measured by objective response rate (ORR) at one month.
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Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155)
Rochester, MN
This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites. During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose ...
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A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL. MOR00208 is an investigational drug. RTX and BEN are both approved in many countries for the treatment of lymphomas. The combination of both is considered and recommended by some medical authorities in some other countries as an option to treat DLBCL.
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Phase 2 Study with TTI-622 and TTI-621 in Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of ths study is to find out more about the side effects of two new drug combinations for lymphoma, TTI-621 and pembrolizumab and TTI-622 and pembrolizumab, and what doses of TTI-621 and TTI-622 are safe for people to take. In addition, we want to learn if the drug combinations help your cancer.
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Ascorbic Acid and Combination Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma or CCUS
Rochester, MN; La Crosse, WI; Eau Claire, WI; Mankato, MN
The purpose of this study is to examine how well ascorbic acid and combination chemotherapy work in treating patients with lymphoma that has come back or does not respond to therapy. Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better at treating lymphoma.
In the Clonal Cytopenia of Undetermined Significance (CCUS) Cohort D, we want to find out if ascorbic acid will ...
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A Study to Evaluate the Use of Nivolumab and Pomalidomide Combination for Relapsed/Refractory Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone ...
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FT819 in Subjects With B-cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and clinical activity of FT819 in r/r B-cell malignancies, including the effect of a step-fractionated dosing schedule on mitigating safety risks and improving tolerability.
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Study to Evaluate CCS1477 in Haematological Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is primarily designed to evaluate the safety and tolerability of CCS1477 in patients with relapsed or refractory acute myeloid leukaemia (AML)/high-risk myelodysplastic syndrome (MDS), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL; B or T-cell).
CCS1477 is a potent, selective and orally bioavailable inhibitor of the bromodomain of p300 and CBP, critical transcriptional co-activators of genes that drive cell proliferation and survival. The compound causes G1 cell cycle arrest and is anti-proliferative across a broad range of haematological cell models, representative of AML, MM and lymphomas. This is also accompanied by an increase in myeloid differentiation in ...
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Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.
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A Safety Study of SEA-TGT (SGN-TGT) in Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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A Study to Evaluate Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
Rochester, MN
The primary purpose of this study is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.
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Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
Rochester, MN
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.
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Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors
Rochester, MN
The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.
Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.
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A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Study of TJ011133 in Participants With Relapsed/ Refractory Advanced Solid Tumors and Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.