Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT03147612|
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Acute Lymphoblastic Leukemia Acute Myeloid Leukemia With BCR-ABL1 Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Philadelphia Chromosome Positive Recurrent Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia||Biological: Blinatumomab Drug: Cyclophosphamide Drug: Cytarabine Biological: Filgrastim Drug: Methotrexate Biological: Pegfilgrastim Drug: Ponatinib Biological: Rituximab Drug: Vincristine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||February 8, 2018|
|Estimated Primary Completion Date :||February 8, 2024|
|Estimated Study Completion Date :||February 8, 2024|
Experimental: Treatment (chemotherapy, ponatinib, blinatumomab)
See Detailed Description.
Given via central catheter
Given intrathecally or IV
Given intrathecally or IV
- Complete molecular response (CMR) in newly diagnosed Philadelphia chromosome (Ph)-positive and/or BCR-ABL-positive participants [ Time Frame: Up to 84 days (3 courses) ]The CMR rate within the first 3 courses for cohort 1 or rate within the first 2 courses for cohort 2 will be estimated along with the 95% credible intervals. Similar analyses will be performed for estimating the rate of complete cytogenetic response and major molecular response rates.
- Overall response (OR) in participants with relapsed/refractory acute lymphoblastic leukemia [ Time Frame: Up to 6 years ]Overall response is defined as complete response (CR) + complete response with hematologic improvement (CRi) in participants with relapsed/refractory disease.
- Complete cytogenetic response [ Time Frame: Up to 6 years ]Will be estimated along with the 95% credible intervals.
- CMR for relapsed/refractory population [ Time Frame: Up to 6 years ]Will be estimated along with the 95% credible intervals.
- Event-free survival (EFS) [ Time Frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 6 years ]The Kaplan-Meier method will be used to assess EFS probabilities for each cohort.
- Overall survival (OS) [ Time Frame: From the first day of treatment to time of death from any cause, assessed up to 6 years ]The Kaplan-Meier method will be used to assess OS probabilities for each cohort.
- Incidence of adverse events (AEs) [ Time Frame: Up to 6 years ]Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
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): NCT03147612
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Elias Jabbour 713-792-4764 firstname.lastname@example.org|
|Principal Investigator: Elias Jabbour|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|