Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT04094142|
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-hodgkin Lymphoma,B Cell||Drug: Acalabrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma|
|Actual Study Start Date :||July 9, 2019|
|Estimated Primary Completion Date :||July 9, 2021|
|Estimated Study Completion Date :||December 9, 2021|
Experimental: Treatment arm
Acalabrutinib is provided as hard gelatin capsules for oral administration. Acalabrutinib 100 mg will be administered approximately every 12 hours from day 1 to day 28 Rituximab is provided as single-use vials for intravenous administration only. Rituximab 375 mg/m2 will be administered on day 1.
Lenalidomide is provided as opaque hard capsules for oral administration. Lenalidomide 20 mg will be administered once daily from day 1 to day 21
Acalabrutinib, lenalidomide, rituximab will be given as described in the "Arms" decriptions. Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, for 6 cycles.
After 6 cycles, maintenance of acalabrutinib 100mg bid will be administered up to 1 year for subjects whose best responses- to the regimen are partial response or complete remission.
- Objective Response Rate (ORR) [ Time Frame: within 4 weeks after the 6 cycles of combination therapy (each cycle is 28 days) ]ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Lugano criteria
- Duration of response [ Time Frame: Tumor status will be assessed at Week 8, 16, 24 (± 7 days), then every 3 months (± 14 days) ]
- Complete remission rate [ Time Frame: Response will be assessed at Week 8, 16, 24 (± 7 days) ]
- Progression free survival [ Time Frame: Tumor status will be assessed at Week 8, 16, 24 (± 7 days), then every 3 months (± 14 days) ]
- Overall survival [ Time Frame: Tumor status will be assessed at Week 8, 16, 24 (± 7 days), then every 3 months (± 14 days) ]
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): NCT04094142
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 03080|
|Contact: Youngil Koh, MD, PhD 82-02-2072-2217 firstname.lastname@example.org|