Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04566887|
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : March 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Acalabrutinib Drug: R-CHOP chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Acalabrutinib in Combination With R-CHOP Chemotherapy in Previously Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||October 1, 2023|
|Estimated Study Completion Date :||October 1, 2025|
Experimental: Acalabrutinib with R-CHOP chemotherapy
Acalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles.
Administered as 100mg tablets.
Drug: R-CHOP chemotherapy
- Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma [ Time Frame: 1-2 weeks after completing six cycles (21 days) of R-CHOP + acalabrutinib. ]
- Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0 [ Time Frame: Baseline through end of study treatment (up to 18 weeks) ]
- Measures of efficacy by using the RECIL 2017 criteria. [ Time Frame: Baseline to end of study (up to 2 years) ]
- Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry [ Time Frame: Up to 18 weeks ]
- Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry [ Time Frame: Baseline to end of study (up to 2 years) ]
- Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym [ Time Frame: Baseline to end of study (up to 2 years) ]Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).
- Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity [ Time Frame: Baseline to end of study (up to 2 years) ]
- Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog [ Time Frame: Baseline to end of study (up to 2 years) ]Participants rated their cognitive function on a scale of 0 to 4 where 0 was never and 4 was several times a day.
- Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30 [ Time Frame: Baseline to end of study (up to 2 years) ]Participants rated their quality of life on a scale of 1 to 4 where 1 was not at all and 4 was very much.
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): NCT04566887
|Contact: John Kuruvilla, M.D.||416-946-2821||John.Kuruvilla@uhn.ca|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: Diego Villa email@example.com|
|Princess Margaret Cancer Centre||Not yet recruiting|
|Toronto, Ontario, Canada|
|Centre Hospitalier Universitaire de Québec||Not yet recruiting|
|Quebec City, Quebec, Canada, G1J 1Z4|
|Contact: Jean-Francois Larouche firstname.lastname@example.org|