NCT00720109|CompletedPhase 2Results

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2009-00312AALL0622CDR000060021708-829COG-AALL0622U10CA098543

Study Type

interventional

Target

Locations

5 countries

Sites

134

Timeline

RegisteredJul 2008

StartedJul 2008

CompletionMar 2020

Brief Summary

This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jul 2008

Longer than P75 for phase_2

Geographic Reach

5 countries

134 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.7 years study duration

Study Start

First participant enrolled

July 14, 2008

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

October 7, 2016

Completed

3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed

Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

6.5 years

First QC Date

July 19, 2008

Results QC Date

September 8, 2016

Last Update Submit

April 4, 2020

Conditions

Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Outcome Measures

Primary Outcomes (2)

Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.
At 3 years
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)
Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

Secondary Outcomes (3)

Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
At the end of induction therapy (at 5 weeks)
Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
At end of consolidation (at 11 weeks)
Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Study Arms (1)

Treatment (enzyme inhibitor therapy and chemotherapy)

EXPERIMENTAL

See Detailed Description

Drug: AsparaginaseDrug: CyclophosphamideDrug: CytarabineDrug: DasatinibDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: EtoposideBiological: FilgrastimDrug: Hydrocortisone Sodium SuccinateDrug: IfosfamideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: MethylprednisoloneDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: Vincristine Sulfate

Interventions

AsparaginaseDRUG

Given IT

Also known as: ASP-1, Asparaginase II, Asparaginase-E.Coli, Colaspase, Elspar, Kidrolase, L-Asnase, L-ASP, L-asparaginase, L-Asparagine amidohydrolase, Laspar, Lcf-ASP, Leucogen, Leunase, MK-965, Paronal, Re-82-TAD-15, Serasa, Spectrila