An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT02180724|
Recruitment Status : Active, not recruiting
First Posted : July 3, 2014
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Waldenström Macroglobulinemia (WM)||Drug: Acalabrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2021|
Experimental: Previously Treated
Previously treated, N=92
Experimental: Treatment Naïve
Treatment Naïve, N=14
- Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator [ Time Frame: Up to approximately 3.8 years. Data cut at when last patient have completed Cycle 27 (28 days per Cycle). ]ORR defined as the rate of subjects achieving a Miner Response (MR) or better including complete response (CR), very good partial response (VGPR), partial response (PR) and MR; The definition of responses are evaluated by investigators using both Modified 6th criteria (refer to protocol table 4-2 , 4-3) and Modified 3rd International Workshop of Waldenström Macroglobulinemia (IWWM) criteria (refer to protocol table 4-4 and table 4-5 for definition). For Modified 6th criteria, MR is defined as (1) monoclonal IgM protein is detectable, (2) no new signs or symptoms of active disease, (3) and patient has >=25% but < 50% reduction in serum monoclonal IgM level from baseline. PR and VGPR both require (1) and (2) as MR, but PR also requires the >=50% and <90% reduction in serum monoclonal IgM level as well as reduction in extramedullary disease. VGPR requires >= 90% reduction in serum IgM and complete resolution of extramedullary disease.
- Progression-free Survival (PFS) of Acalabrutinib by Investigator [ Time Frame: Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle). ]Kaplan-Meier (K-M) estimates of the PFS assessments and its 95% confidence interval are provided using both modified 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive or have not progressed by the given time over all patients at risk. Per 6th IWWM criteria, the progressive disease is defined as >= 25% increase in serum IgM level with an absolute increase of at least 500 mg/dL from lowest nadir (requires confirmation on at least 2 consecutive measurements at least 4 weeks apart) and/or progression of clinical features attributable to the disease. Per modified 3rd IWWM criteria, besides IgM requirement as 6th criteria, it could also includes progression of clinically significant disease related symptoms and/or death from any cause or initiation of a new anti-neoplastic therapy.
- Overall Survival (OS) of Acalabrutinib by Investigator [ Time Frame: Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27. ]Kaplan-Meier (K-M) estimates of the OS assessments and its 95% confidence interval are provided using both 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive by the given time over all patients at risk.
- Summary of Duration of Response (DOR) [ Time Frame: Primary analysis occur when all subjects have completed Cycle 27 or have excit the study ]DOR is defined as the interval from the first documentation of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minor Response (MR) to the earlier of the first documentation of definitive PD or death from any cause. The summary statistics are provided for DOR.
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): NCT02180724
|United States, District of Columbia|
|Washington, District of Columbia, United States|
|United States, New York|
|New York, New York, United States|
|United States, Texas|
|Houston, Texas, United States|
|Leicester, United Kingdom|
|Study Director:||Acerta Clinical Trials||1-888-292-9613; firstname.lastname@example.org|