Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT02689440|
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia||Drug: Dasatinib Other: Laboratory Biomarker Analysis Drug: Venetoclax||Phase 2|
I. To estimate the proportion of patients with previously-untreated chronic phase chronic myeloid leukemia (CML) who achieve major molecular response by 12 months of treatment with dasatinib 50 mg orally daily (first 70 patients) and of dasatinib 50 mg daily in combination with venetoclax 200 mg daily starting after 3 months of dasatinib therapy (after protocol amendment).
I. To estimate the 12 months molecular response (MR)4.5 rate and the cumulative overall rate of MR4.5 (BCR-ABL transcripts [IS] =< 0.01%).
II. To estimate the proportion of patients with MR4.5 at 6-, 12-, 18-, 24-, and 36-months of therapy.
III. To estimate the proportion of patients with sustained MR4.5 of 3 years and more.
IV. To estimate the treatment-free remission rate, time to progression, and overall survival.
V. To assess the safety of this combination.
Patients receive dasatinib orally (PO) once daily (QD) for 15 years in the absence of disease progression or unacceptable toxicity. After 3 months of dasatinib treatment, patients also receive venetoclax PO QD on days 1-14 of each month for 3 years in the absence of disease progression or unacceptable toxicity (patients enrolled prior to 4/1/2018 receive only dasatinib).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib and Venetoclax: A Phase II Study|
|Actual Study Start Date :||February 19, 2016|
|Estimated Primary Completion Date :||December 31, 2040|
|Estimated Study Completion Date :||December 31, 2040|
Experimental: Treatment (dasatinib, venetoclax)
Patients receive dasatinib PO QD for 15 years in the absence of disease progression or unacceptable toxicity. After 3 months of dasatinib treatment, patients also receive venetoclax PO QD on days 1-14 of each month for 3 years in the absence of disease progression or unacceptable toxicity (patients enrolled prior to 4/1/2018 receive only dasatinib).
Other: Laboratory Biomarker Analysis
- Major molecular response (MMR) defined as BCR-ABL transcripts (IS) =< 0.1% [ Time Frame: Up to 12 months ]MMR estimates will be presented with 95% credible intervals. MMR and patient and clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test.
- Complete cytogenetic response (CCR) defined as 0% Ph-positive metaphases, or fluorescence in situ hybridization =< 2%, or BCR-ABL transcripts (IS) =< 1% [ Time Frame: At 6 months ]CCR estimates will be presented with 95% credible intervals.
- Incidence of toxicities, defined as grade 3 or higher pleural effusion [ Time Frame: Up to 3 years ]Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range (i.e., duration of hematologic, cytogenetic and molecular response to the drug).
- Time to progression [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
- Overall survival [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
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): NCT02689440
|Contact: Hagop Kantarjianfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Hagop M. Kantarjian 713-792-7026 email@example.com|
|Principal Investigator: Hagop M. Kantarjian|
|Principal Investigator:||Hagop M Kantarjian||M.D. Anderson Cancer Center|