Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03863184
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib, oral, 100 mg BID, continuous
  • Lenalidomide — DRUG
    Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
  • Rituximab — DRUG
    Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
  • Obinutuzumab — DRUG
    Obinutuzumab on days 1, 8, 15 of cycle 1, day 1 of cycles 2-6, then every 2 cycles

Study Details

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.

Key Dates

Start date
Oct 11, 2019
Status verified
Apr 2026
Primary completion
Apr 25, 2024
Completion
May 30, 2028

Study Design

Enrollment
37 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ALR in Combination
    Acalabrutinib, lenalidomide, and rituximab in combination
  • Experimental: ALO in Combination
    Acalabrutinib, lenalidomide and obinutuzumab in combination

Primary Outcome Measure

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 [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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