Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Major Inclusion Criteria:
- Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including
one of the following diagnoses by 2016 World Health Organization (WHO) classification
of lymphoid neoplasms are eligible:
1. DLBCL, NOS including GCB type, ABC type
2. T-cell rich large BCL
3. Epstein-Barr virus-positive DLBCL, NOS
4. Anaplastic lymphoma kinase (ALK)-positive large BCL
5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6
(BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients
must be appropriate candidates for R-CHOP. If an investigator deems a patient
with a known double- or triple-hit lymphoma (HGBL) should be treated more
aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine,
cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide,
vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and
cytarabine [Hyper CVAD]), this patient would not be considered eligible for this
study
7. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT
lymphoma or non-gastric MALT lymphoma
8. FL grade 3b
- Availability of archival or freshly collected tumor tissue sent for retrospective
central pathology review
- IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤
60 years of age)
- Diagnosis to treatment interval, defined as the time between the date of DLBCL
diagnosis (date of the first biopsy specimen containing lymphoma according to the
local pathology report) and the start of treatment (C1D1) ≤ 28 days
- ECOG performance status of 0, 1, or 2
- Left ventricular ejection fraction equal to or greater than lower limit of
institutional normal range, assessed by local echocardiography or cardiac multi-gated
acquisition (MUGA) scan
- Adequate hematologic function
- Female participants: Agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive methods and refrain from breast feeding and donating
eggs; agreement to ongoing pregnancy testing during the course of the study, and after
study therapy has ended
- Male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use a condom and agreement to refrain from donating sperm
Major Exclusion Criteria:
- Any other histological type of lymphoma according to WHO 2016 classification of
lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma,
Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary
cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or
indolent lymphoma
- History of prior non-hematologic malignancy except for the following:
1. Malignancy treated with curative intent and with no evidence of active disease
present for more than 2 years before screening
2. Adequately treated lentigo maligna melanoma without current evidence of disease
or adequately controlled non-melanomatous skin cancer
3. Adequately treated carcinoma in situ without current evidence of disease
- Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1,
except for permitted pre-phase treatment
- Contraindication to any of the individual components of R-CHOP, including prior
receipt of anthracyclines
- Known CNS lymphoma involvement
- Known active systemic bacterial, viral, fungal, or other infection at screening,
including patients with suspected active or latent tuberculosis (as confirmed by a
positive interferon-gamma release assay)
- History or evidence of clinically significant cardiovascular, CNS and/or other
systemic disease that in the investigator's opinion would preclude participation in
the study or compromise the patient's ability to give informed consent
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.