Active — Not RecruitingPhase 2

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

United States37 participantsStarted 2019-10-11

Plain-language summary

This is a multi-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) and acalabrutinib, lenalidomide and obinutuzumab (ALO) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR or ALO. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR or ALO until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed diagnosis of mantle cell lymphoma * Age ≥ 18 years * No prior systemic therapy for lymphoma * Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in two dimensions; measurable spleen disease is allowed * Treatment should be indicated according to the treating physician * ECOG performance status ≤ 2 * Required initial laboratory parameters: * Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 * Platelet count ≥ 75,000 cells/mm3 * Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula * Total bilirubin ≤ 2.0 x ULN * AST/SGOT and ALT/SGPT ≤ 3.0 x ULN * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use low molecular weight heparin). * All subjects must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®. * Patients of reproductive potential agree to use birth control throughout their participation in this study, and for 28 days following study termination. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 d…

What they're measuring

Peripheral Blood Minimum Residual Disease (MRD)-Negative Complete Response (CR) Rate of the Combination of Acalabrutinib + Lenalidomide + Rituximab at the Conclusion of 12 Cycles of Induction Therapy

Timeframe: 1 year

Trial details

NCT IDNCT03863184

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-25

Results submitted2025-04-15