Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL
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|ClinicalTrials.gov Identifier: NCT03863184|
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Acalabrutinib Drug: Lenalidomide Drug: Rituximab||Phase 2|
This is a single-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma.
The study includes an induction phase consisting of 12 cycles of ALR. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects in complete response wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection.
Subjects will be monitored for Minimal Residual Disease (MRD) status in peripheral blood at baseline and completion of 12 cycles of induction treatment using Adaptive Biotechnology Clonoseq assay, and then every 4 cycles.
Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Study intervention begins with an induction phase consisting of 12 cycles of acalabrutinib, lenalidomide, and rituximab (ALR). Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects in CR wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection.|
|Masking:||None (Open Label)|
|Official Title:||A Multiple-center Phase 2 Study of Acalabrutinib-Lenalidomide-Rituximab in Patients With Previous Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||October 11, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2024|
Experimental: ALR in Combination
Acalabrutinib, lenalidomide, and rituximab in combination
Acalabrutinib, oral, 100 mg BID, continuous
Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
Other Name: Revlimid
Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
Other Name: Rituxan
- 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 ]Percentage of subjects with MRD-negative CR at the conclusion of 12 cycles of induction therapy. Each cycle is 28 days, 12 cycles is approximately 1 year.
- Safety of combination treatment with acalabrutinib, lenalidomide, and rituximab as measured by the percentage of subjects that experience 1 or more adverse event [ Time Frame: 4 years ]Rate of subjects that experience 1 or more adverse events
- Overall response rate [ Time Frame: 4 years ]Rate of subjects who achieve a partial or complete response
- Complete response rate [ Time Frame: 4 years ]Rate of subjects who achieve a complete response
- Progression free survival [ Time Frame: 4 years ]Measured from start of treatment to time of progression or death from any cause, measured in months
- Overall survival [ Time Frame: 4 years ]Measured from start of treatment to death from any cause, measured in months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863184
|Contact: Amelyn Rodriguez, R.N.||firstname.lastname@example.org|
|Contact: Rita Vaccaro, R.N.||email@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Amelyn Rodriguez, R.N. 212-746-1362 firstname.lastname@example.org|
|Contact: Rita Vaccaro, R.N. 212-746-0702 email@example.com|
|Principal Investigator: Jia Ruan, M.D., Ph.D.|
|Principal Investigator:||Jia Ruan, M.D., Ph.D.||Weill Cornell Medicine|