Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07724457
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Recurrent Burkitt Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
  • Refractory Burkitt Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and/or cerebrospinal fluid collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Carboplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV or IT
  • Doxorubicin — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Glofitamab — BIOLOGICAL
    Given IV
  • Ifosfamide — DRUG
    Given IV
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Methotrexate — DRUG
    Given IV or IT
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Rituximab and Hyaluronidase Human — BIOLOGICAL
    Given SC
  • Survey Administration — OTHER
    Ancillary studies
  • Vincristine — DRUG
    Given IV

Study Details

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.

Key Dates

First listed
Jul 24, 2026
Start date
Oct 30, 2026
Status verified
Aug 2026
Primary completion
Nov 1, 2033
Completion
Nov 1, 2033

Study Design

Enrollment
271 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 arm 2 RCODOXM/RIVAC or DA-REPOCH and glofitamab)
    See Detailed Description
  • Experimental: Cohort 1, arm 1 RCODOXM/RIVAC or DA-REPOCH)
    See Detailed Description.
  • Experimental: Cohort 2 arm 3 (DA-REPOCH)
    Patients 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.
  • Experimental: Cohort 2 arm 4 (DA-REPOCH and glofitamab)
    Patients 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.
  • Experimental: Cohort 3 (RICE and glofitamab)
    See Detailed Description

Primary Outcome Measure

Progression free survival (PFS) (cohort 1) (phase II) [ Time Frame: from randomization to the time of documented disease progression or death due to any cause ]

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