Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01460160|
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : August 21, 2018
Last Update Posted : December 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Pediatric||Drug: Dasatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||April 13, 2012|
|Actual Primary Completion Date :||May 28, 2017|
|Actual Study Completion Date :||June 1, 2021|
|Experimental: Arm 1: Dasatinib||
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Name: Sprycel
- 3-year Event-free Survival (EFS) Rate [ Time Frame: From first dose to 3 years following first dose ]
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment.
Events for EFS are defined as ANY first one of the following:
- Lack of complete response in bone marrow
- Relapse at any site
- Development of second malignant neoplasm
- Death from any cause
- Number of Participants Experiencing Adverse Events [ Time Frame: From first dose to 100 days following last dose (up to approximately 23 months) ]Number of participants experiencing different types of all causality all grade adverse events
- Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) [ Time Frame: From first dose to 3 years or 5 years following first dose ]Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
- Complete Remission Rate [ Time Frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) ]Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
- Percentage of Participants Negative for Minimal Residual Disease (MRD) [ Time Frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) ]MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
- Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse [ Time Frame: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) ]A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
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): NCT01460160
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|