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Clinical Studies
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A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors.
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Assessment of frailty and clonal hematopoiesis in adults with hematological diagnosis
Rochester, Minn.
The purpose of this study is to assess the frailty and clonal hematopoiesis (CH) in hematology malignancy patients.
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Cell, Serum, and Buccal Bank for Patients with Acute or Chronic Myeloid Disorders
Rochester, Minn.
This study is being done to store blood, buccal (cheek) cells, genetic material including DNA (deoxyribonucleic acid) and RNA (ribonucleic acid), and bone marrow so that they can be used for laboratory studies that may contribute to finding the causes of disease and factors that may determine disease progression and treatment response.
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INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN) (INTERCEPTN)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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MC210807 Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) Relapsed/Refractory or Intolerant to Available Therapies
Rochester, Minn.
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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Methylation and Chromatin Abnormalities in Myelodysplastic Syndromes
Rochester, Minn.
The purpose of this study is to assess tumor cells from blood and bone marrow from patients with myeloid neoplasms for epigenetic dysregulation and abnormalities of chromatin and for immune activation and exhaustion.
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Pre-myeloid Cancer and Bone Marrow Failure Clinic Study
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test a new technology called Next Generation Sequencing (NGS) that may help identify this risk associated with precursor conditions and the likelihood that they will change into overt blood and bone marrow cancers. NGS is a procedure that looks at relevant cancer associated genes and what they do.
Closed for Enrollment
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A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 w/Intermediate-2 & High Risk Myelodysplastic Syndrome (BMT CTN #1102)
Rochester, Minn.
This study is designed as a multicenter trial, with biological assignment to one of two study arms;
Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT),
Arm 2: Non-Transplant Therapy/Best Supportive Care.
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A Phase 1 Study of Lenzilumab (KB003) in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
Rochester, Minn.
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
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A Phase I/II, Multi-Center Study of Mocetinostat (MGCD0103) in Combination With Azacitidine in Subjects With Intermediate or High Risk Myelodysplastic Syndrome (MDS)
Rochester, Minn.
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.
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A Phase II Open-Label, Single-arm, Two-Stage, Multicenter Trial of Pracinostat in Combination With Azacitidine in Elderly (Age 65 Years or Older) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Rochester, Minn.
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)
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A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia (RADIUS)
Rochester, Minn.
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
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A Randomized Phase II/III Study of Azacitidine in Combination With Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination With Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This randomized phase II/III trial studies how well giving azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.
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A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (73) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IAV) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML)
Rochester, Minn.
This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.
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A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Rochester, Minn.
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.
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AML-03 - Pilot Study of IGF-Methotrexate Conjugate in the Treatment of Myelodysplastic Syndrome, CMML and Oligoblastic AML
Rochester, Minn.
The primary objective of this study is to determine the safety and tolerability of utilizing the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of advanced, previously treated myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML), including determining the maximum tolerated dose (MTD).
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Collection of Pharmacogenomics (PGx) Results and Clinical Data of Patients with Chronic Myeloid Leukemia and Lung Cancer to Assess Current and Future Therapeutic Relevance
Rochester, Minn.
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for a group of patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of medications.
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KO-TIP-004 - A Phase 2 Study of Tipifarnib in Subjects with Chronic Myelomonocytic Leukemia, Other Myelodysplastic /Myeloproliferative Neoplasias, and Acute Myeloid Leukemia
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment until disease progression. If a complete response is observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start of response.
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Phase 3 Study of US-ATG-F to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients After Allogeneic Stem Cell Transplantation From Unrelated Donors
Rochester, Minn.
The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.
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Qualitative Interviews to Evaluate the Content Validity of Patient- Reported Outcomes for Use in Myelodysplastic Syndromes (MDS)
Rochester, Minn.
The primary objective of this study is to generate evidence for the content validity of the Functional Assessment of Cancer Therapy - Anemia (FACT-An) and the Quality of Life in Myelodysplasia Scale (QUALMS) for use in an MDS population. Specifically, the study aims to gain an understanding of the experience of patients with MDS, including the key symptoms and impacts, as well as assess the patient understanding and relevance of the FACT-An and QUALMS for use in patients with MDS such that they may be used as trial endpoints.
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Randomized Phase II Trial of Timed Sequential Cytosine Arabinoside (ara-C) with and without the Checkpoint Kinase 1 (CHK1) Inhibitor MK-8776 in Adults with Relapsed AML
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
This randomized phase II trial studies how well cytarabine with or without SCH 900776 works in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.
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Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML)
Rochester, Minn.,
Jacksonville, Fla.
This is a non-randomized open label multi-center study. Patients with high-risk myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia [CMML]) will be treated with SL-401, which will be administered as a brief intravenous infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 4 myeloproliferative malignancies: SM, PED, MF, and CMML. In entirety, the Stage 2 portion will consist of up to 72 patients who will be treated at a maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
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