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Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

NCT03863184 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-04-28

Study results available
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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.

Conditions

Interventions

DRUG

Acalabrutinib

Acalabrutinib, oral, 100 mg BID, continuous

DRUG

Lenalidomide

Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles

DRUG

Rituximab

Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4

DRUG

Obinutuzumab

Obinutuzumab on days 1, 8, 15 of cycle 1, day 1 of cycles 2-6, then every 2 cycles

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jia Ruan, M.D., Ph.D. · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2024-04-25
Completion
2028-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863184 on ClinicalTrials.gov