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NCT07444710

Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 33 versions: 3 with changes below, 30 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Notable Start date pushed from Oct 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Notable Start date: Aug 20, 2026 to Oct 30, 2026v32
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of adverse events (AEs)
Timeframe: Up to 5 years
Dose limiting toxicity (DLT)
Timeframe: From cycle 2, day 8 to cycle 5 day 1 (cycle length = 21 days)

Secondary (5)

Overall response rate
Complete response rate
Partial response rate
Failure free survival
Overall survival

Arms and interventions

Treatment (glofitamab with R-CHOP/R-DHAP)Experimental

INDUCTION: CYCLES: 1, 3 and 5: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, as well as prednisone PO on days 1-5. Starting with cycle 3, patients also receive glofitamab IV, over 2-8 hours, on day 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 2, 4 and 6: Patients receive rituximab IV, and cisplatin IV over 24 hours on day 1, as well as cytarabine IV on day 2 and dexamethasone PO on days 1-4. Patients also receive glofitamab IV, over 2-8 hours, on days 8 and 15 of cycle 2 and on day 8 of subsequent cycles. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive glofitamab IV on day 1 of each cycle. Cycles repeat every 21 days for a total of 24 months of treatment, in the absence of disease progression or unacceptable toxicity.

Procedures: Biospecimen Collection, Computed Tomography, Positron Emission Tomography

Drugs: Cisplatin, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Prednisone, Vincristine

Biologicals: Glofitamab, Rituximab