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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00720109
Registration number
NCT00720109
Ethics application status
Date submitted
19/07/2008
Date registered
22/07/2008
Date last updated
13/04/2020
Titles & IDs
Public title
Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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Scientific title
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
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Secondary ID [1]
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NCI-2009-00312
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Secondary ID [2]
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NCI-2009-00312
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Asparaginase
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dasatinib
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Etoposide
Treatment: Other - Filgrastim
Treatment: Drugs - Hydrocortisone Sodium Succinate
Treatment: Drugs - Ifosfamide
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Methylprednisolone
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Prednisone
Treatment: Other - Radiation Therapy
Treatment: Drugs - Vincristine Sulfate
Experimental: Treatment (enzyme inhibitor therapy and chemotherapy) - See Detailed Description
Treatment: Drugs: Asparaginase
Given IT
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT or IV
Treatment: Drugs: Dasatinib
Given PO
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given IV or PO
Treatment: Drugs: Etoposide
Given IV
Treatment: Other: Filgrastim
Given IV or SC
Treatment: Drugs: Hydrocortisone Sodium Succinate
Given IT
Treatment: Drugs: Ifosfamide
Given IV
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given IV or PO
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT, PO, or IV
Treatment: Drugs: Methylprednisolone
Given IV
Treatment: Drugs: Pegaspargase
Given IM
Treatment: Drugs: Prednisone
Given PO or IV
Treatment: Other: Radiation Therapy
Some patients undergo cranial RT
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
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Assessment method [1]
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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.
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Timepoint [1]
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At 3 years
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Primary outcome [2]
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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
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Assessment method [2]
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Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)
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Timepoint [2]
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Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
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Secondary outcome [1]
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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
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Assessment method [1]
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Percent of patients MRD Positive (MRD \> 0.01%) at End of Induction.
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Timepoint [1]
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At the end of induction therapy (at 5 weeks)
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Secondary outcome [2]
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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
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Assessment method [2]
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A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.
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Timepoint [2]
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At end of consolidation (at 11 weeks)
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Secondary outcome [3]
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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
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Assessment method [3]
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An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.
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Timepoint [3]
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From the time entry on study to first event or date of last follow-up, assessed up to 7 years
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Eligibility
Key inclusion criteria
* Newly diagnosed acute lymphoblastic leukemia (ALL)
* Definitive evidence of BCR-ABL fusion (Philadelphia chromosome positive [PH+]) from an approved Children's Oncology Group (COG) cytogenetics laboratory
* Meets one of the following criteria:
* Concurrent enrollment on Clusters of Orthologous Groups (COG)-AALL03B1 (or a successor trial) AND COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial
* Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND scheduled to receive a 3 or 4-drug standard induction regimen
* Concurrent enrollment on a Dana-Farber Cancer Institute (DFCI) Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
* All patients must have definitive evidence of BCR-ABL fusion from an approved COG cytogenetics laboratory; patients may NOT have received Day 15 of Induction chemotherapy (or day 18 vincristine if enrolled on a DFCI Childhood ALL Consortium trial) prior to enrollment on AALL0622
* Patients must have a performance status of 0, 1 or 2 at completion of two weeks of Induction; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or maximum serum creatinine based on age and gender as follows:
* 0.4 mg/dL (for patients 1 to 5 months of age)
* 0.5 mg/dL (for patients 6 to 11 months of age)
* 0.6 mg/dL (for patients 1 year of age)
* 0.8 mg/dL (for patients 2 to 5 years of age)
* 1.0 mg/dL (for patients 6 to 9 years of age)
* 1.2 mg/dL (for patients 10 to 12 years of age)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years of age)
* Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN for age
* Shortening fraction >= 27% by echocardiogram or ejection fraction >= 50% by gated radionuclide study
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination
* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided
* Patients will start AALL0622 therapy on day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial); patients must have received the first 2 weeks of Induction therapy
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Minimum age
2
Years
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Maximum age
30
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
* Female patients who are lactating must agree to stop breast-feeding
* Patients with Down syndrome
* Patients with any clinically significant cardiovascular disease including the following:
* Myocardial infarction or ventricular tachyarrhythmia within 6 months
* Ejection fraction less than institutional normal
* Major conduction abnormality (unless a cardiac pacemaker is present)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2020
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Sample size
Target
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [2]
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Royal Children's Hospital-Brisbane - Herston
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Women's and Children's Hospital-Adelaide - North Adelaide
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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5006 - North Adelaide
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Recruitment postcode(s) [3]
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6008 - Perth
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Recruitment outside Australia
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Funding & Sponsors
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Government body
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Name
National Cancer Institute (NCI)
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00720109
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Trial related presentations / publications
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. Slayton WB, Schultz KR, Kairalla JA, Devidas M, Mi X, Pulsipher MA, Chang BH, Mullighan C, Iacobucci I, Silverman LB, Borowitz MJ, Carroll AJ, Heerema NA, Gastier-Foster JM, Wood BL, Mizrahy SL, Merchant T, Brown VI, Sieger L, Siegel MJ, Raetz EA, Winick NJ, Loh ML, Carroll WL, Hunger SP. Dasatinib Plus Intensive Chemotherapy in Children, Adolescents, and Young Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Results of Children's Oncology Group Trial AALL0622. J Clin Oncol. 2018 Aug 1;36(22):2306-2314. doi: 10.1200/JCO.2017.76.7228. Epub 2018 May 29.
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Public notes
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Contacts
Principal investigator
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William B Slayton
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Children's Oncology Group
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00720109
Download to PDF