TriangleNCT01460160 · CITED IN SOURCE DOCUMENTS
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2021-12-08
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
3-year Event-free Survival (EFS) Rate
Number of Participants Experiencing Adverse Events
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
Complete Remission Rate
Percentage of Participants Negative for Minimal Residual Disease (MRD)
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL) * Age \>1 year and \< less than 18 years old * Induction chemotherapy ≤ 14 days according to institutional standard of care * Adequate liver, renal and cardiac function Exclusion Criteria: * Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor * Extramedullary involvement of the testicles * Active systemic bacterial, fungal or viral infection * Down syndrome
- healthy Volunteers
- false
- maximum Age
- 17 Years
- minimum Age
- 1 Year
- sex
- ALL
- std Ages
- CHILD
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Dasatinib
- label
- Arm 1: Dasatinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm 1: Dasatinib
- description
- Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
- name
- Dasatinib
- other Names
- Sprycel
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 106
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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
- measure
- 3-year Event-free Survival (EFS) Rate
- time Frame
- From first dose to 3 years following first dose
- secondary Outcomes
- description
- Number of participants experiencing different types of all causality all grade adverse events
- measure
- Number of Participants Experiencing Adverse Events
- time Frame
- From first dose to 100 days following last dose (up to approximately 23 months)
- description
- 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.
- measure
- Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
- time Frame
- From first dose to 3 years or 5 years following first dose
- description
- 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.
- measure
- 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)
- description
- 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%
- measure
- 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)
- description
- 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.
- measure
- 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)
Full study description
- brief Summary
- The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
Source references
- references
- citation
- Hunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A. Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1.
- pmid
- 37407142
- type
- DERIVED
- citation
- Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.
- pmid
- 33242441
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
- label
- Investigator Inquiry Form
- label
- FDA Safety Alerts and Recalls
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice