Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04189757|
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : August 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Acalabrutinib||Phase 2|
I. To assess the overall response rate (ORR) at the end of 3 cycles of acalabrutinib.
I. To assess the proportion of patients that are progression free without any of the following toxicities at the end of 3 cycles:
Ia. Recurrence of intolerable toxicities previously noted on ibrutinib. Ib. The occurrence of intolerable toxicities related to acalabrutinib defined as: grade 4 neutropenia or thrombocytopenia lasting greater than 7 days or any grade >= 3 non-hematologic toxicity as assessed by the investigator to be related to study drug).
II. To determine the efficacy of acalabrutinib, progression free survival (PFS) and duration of response (DOR) in patients.
III. To assess the safety profile of acalabrutinib in patient's intolerant to ibrutinib.
I. Sequential peripheral blood (PB)/plasma/tissue fine-needle aspiration (FNA) will be stored for evaluation of:
Ia. Clonal evolution with targeted sequencing (seq) and/or whole exome sequencing (WES) in sequential samples.
Ib. Pattern of mutation changes with acalabrutinib. Ic. Response predictors - mutations, cytokine-chemokines. Id. Minimal residual disease (MRD) assay using flow cytometry (FC) and circulating tumor-derived deoxyribonucleic acid (ctDNA) analysis.
Ie. Sequential immunologic studies with cytokines/chemokines, T cells and immunoglobulins.
Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 1 years, then annually for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Acalabrutinib in Ibrutinib-Intolerant Mantle Cell Lymphoma|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||June 15, 2023|
|Estimated Study Completion Date :||June 15, 2023|
Experimental: Treatment (acalabrutinib)
Patients receive acalabrutinib PO BID on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
- Overall response rate (complete response + partial response) [ Time Frame: At the end of cycle 3 (each cycle is 28 days) ]The primary end point will be met if > 50% patients attain response (half of patients responding without intolerance). Logistic regression may be utilized to assess the effect of patient prognostic factors on the response rate. Intent-to-treat analysis will be applied to the eligible patients.
- Incidence of adverse events [ Time Frame: At the end of cycle 3 (each cycle is 28 days) ]Logistic regression may be utilized to assess the effect of patient prognostic factors on the incidence of adverse events. Toxicity and safety data will be summarized by frequency tables for all patients and then will be reviewed for relatedness to acalabrutinib. Per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. Also, time to event and time to event resolution will be calculated.
- Progression free survival [ Time Frame: Up to 6 years ]The distribution of time-to-event endpoints including progression free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
- Overall survival [ Time Frame: Up to 6 years ]The distribution of time-to-event endpoints including overall survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
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): NCT04189757
|Contact: Luhua (Michael) Wangfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Luhua (Michael) Wang 713-792-2860 email@example.com|
|Principal Investigator: Luhua (Michael) Wang|
|Principal Investigator:||Luhua (Michael) Wang||M.D. Anderson Cancer Center|