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NCT07578077

Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of dose limiting toxicities (DLT)
Timeframe: During cycle 1 (Cycle length = 28 days)
Maximum tolerated dose (MTD) of golcadomide
Timeframe: Up to 3 years
MTD of golcadomide in combination with rituximab
Timeframe: Up to 3 years
Overall response rate (ORR)
Timeframe: Up to 3 years
Progression free survival (PFS)
Timeframe: From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 3 years

Secondary (4)

Incidence of adverse events
Duration of response (DOR) of the combination of golcadomide and rituximab
Duration of complete response (DOCR) of the combination of golcadomide and rituximab
Complete response (CR) of the combination of golcadomide and rituximab

Arms and interventions

Phase I (Golcadomide)Experimental

Patients receive golcadomide PO QD on days 1-14 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.

Phase II (Golcadomide, rituximab)Experimental

Patients receive golcadomide PO QD on days 1-14 of each cycle. Patients also receive rituximab IV on days 1, 8, 15 and 22 of cycle 1 and then day 1 of even cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the trial. Patients undergo bone marrow biopsy and may undergo tissue biopsy on study.

Procedures: Biopsy Procedure, Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Positron Emission Tomography

Drugs: Golcadomide

Biologicals: Rituximab

Sites

1 site in 1 country

  • City of Hope Medical CenterDuarte, California, United States