Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma
A Randomized Phase 2/3 Study the Bispecific Antibody (BsAb), Glofitamab, Plus Chemoimmunotherapy in Newly Diagnosed and Relapsed Burkitt and High-Grade (Double Hit) B-Cell Lymphomas With MYC and BCL2 Rearrangements
3 other identifiers
interventional
271
0 countries
N/A
Brief Summary
This phase II/III trial tests adding glofitamab to standard of care chemoimmunotherapy in patients with Burkitt and high grade (double hit) B- cell lymphomas that are newly diagnosed, that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Glofitamab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Obinutuzumab and rituximab are also monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cytarabine and ifosfamide, 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. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Giving glofitamab with standard of care chemotherapy may work well for the treatment of newly diagnosed, relapsed or refractory Burkitt and high grade (double hit) B- cell lymphomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2026
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedStudy Start
First participant enrolled
August 14, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2033
Study Completion
Last participant's last visit for all outcomes
November 1, 2033
July 27, 2026
July 1, 2026
7.2 years
July 22, 2026
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Progression free survival (PFS) (cohort 1) (phase II)
The median PFS will be summarized by sex with corresponding 95% confidence intervals.
from randomization to the time of documented disease progression or death due to any cause
PFS (cohort 1) (phase III)
PFS defined as from randomization to the time of documented disease progression or death due to any cause. Will be as estimated using the methods of Kaplan and Meier. The median PFS and the 24-month PFS rates will be summarized by sex with corresponding 95% confidence intervals.
At 24 months
PFS (cohort 2) (phase II)
The median PFS will be summarized by sex with corresponding 95% confidence intervals.
From randomization to the time of documented disease progression or death due to any cause, up to 5 years
PFS (cohort 2) (phase III)
PFS defined as from randomization to the time of documented disease progression or death due to any cause. Will be as estimated using the methods of Kaplan and Meier. The median PFS and the 24-month PFS rates will be summarized by sex with corresponding 95% confidence intervals.
At 24 months
Overall survival (cohort 3)
At 12 months after start of treatment
Secondary Outcomes (6)
Overall survival (OS)
From randomization to the time of death due to any cause, up to 5 years
Event free survival (EFS)
From randomization date until the earlier of non-protocol lymphoma therapy, disease progression or death from any cause, up to 5 years
Overall response rate (ORR)
Up to 5 years
Complete response rate
Up to 5 years
Transplant or chimeric antigen receptor t-cell (CAR-T) rate (cohort 3)
Up to 5 years
- +1 more secondary outcomes
Study Arms (5)
Cohort 1 arm 2 RCODOXM/RIVAC or DA-REPOCH and glofitamab)
EXPERIMENTALSee Detailed Description
Cohort 1, arm 1 RCODOXM/RIVAC or DA-REPOCH)
EXPERIMENTALSee Detailed Description.
Cohort 2 arm 3 (DA-REPOCH)
EXPERIMENTALPatients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.
Cohort 2 arm 4 (DA-REPOCH and glofitamab)
EXPERIMENTALPatients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients also receive glofitamab IV, over 2-4 hours, on day 6 and 15 of cycle 2, day 6 of cycle 3-5 and days 6, 22 and 43 of cycle 6. Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. IT treatment can not be given on the same day as glofitamab. Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study.
Cohort 3 (RICE and glofitamab)
EXPERIMENTALSee Detailed Description
Interventions
Undergo blood and/or cerebrospinal fluid collection
Undergo bone marrow biopsy
Given IV
Undergo CT scan
Given IV
Given IV or IT
Given IV
Given IV
Given IV
Given IV
Undergo lumbar puncture
Given IV or IT
Given IV
Undergo PET scan
Given PO
Given IV
Ancillary studies
Given IV
Undergo MRI
Given SC
Eligibility Criteria
You may qualify if:
- BURKITT LYMPHOMA (BL) COHORT 1: Histologically confirmed Burkitt lymphoma by International Consensus Classification criteria. Patients with Burkitt lymphoma must have one or more of the following adverse risk factors at diagnosis:
- Stage III or IV disease
- Elevated lactate dehydrogenase (LDH) greater than institutional upper limit of normal (ULN)
- Tumor mass ≥ 7 cm
- BL COHORT 1: No prior treatment except for pre-phase chemotherapy, pre-phase corticosteroids, or one cycle of chemotherapy as described below.
- Pre-phase chemotherapy with corticosteroids or cyclophosphamide/prednisone is permitted prior to enrollment.
- One cycle of prior chemotherapy (for example, cyclophosphamide, doxorubicin, vincristine and prednisone \[CHOP\], Polatuzumab-cyclophosphamide doxorubicin and prednisone \[CHP\], cyclophosphamide, vincristine, doxorubicin and methotrexate \[CODOXM\], or etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin \[EPOCH\] \[with or without rituximab\]) may be administered no more than 21 days prior to enrollment.
- Patients enrolling on study after one cycle of prior anthracycline containing therapy will start the study therapy in cycle 2 and cycle 2 must occur no later than 22-36 days after the start of cycle 1. (If feasible, cycle 2 should start on day 22, but +14 days is permitted to permit recovery from toxicity in cycle 1)
- BL COHORT 1: Age ≥ 18 years
- BL COHORT 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma
- BL COHORT 1: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (unless attributable to lymphoma)
- BL COHORT 1: Platelet count ≥ 75,000/mm\^3 (unless attributable to lymphoma)
- BL COHORT 1: Calculated (Calc.) creatinine clearance ≥ 50 mL/min (unless attributable to lymphoma)
- BL COHORT 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN (unless attributable to lymphoma)
- BL COHORT 1: Total bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome) (unless attributable to lymphoma)
- +79 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristie A Blum
Alliance for Clinical Trials in Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 24, 2026
Study Start (Estimated)
August 14, 2026
Primary Completion (Estimated)
November 1, 2033
Study Completion (Estimated)
November 1, 2033
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.