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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
Scientific title
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
Secondary ID [1] 0 0
NCI-2009-00312
Secondary ID [2] 0 0
NCI-2009-00312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 0 0
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Timepoint [1] 0 0
At 3 years
Primary outcome [2] 0 0
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Timepoint [2] 0 0
Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
Secondary outcome [1] 0 0
Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Timepoint [1] 0 0
At the end of induction therapy (at 5 weeks)
Secondary outcome [2] 0 0
Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
Timepoint [2] 0 0
At end of consolidation (at 11 weeks)
Secondary outcome [3] 0 0
Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
Timepoint [3] 0 0
From the time entry on study to first event or date of last follow-up, assessed up to 7 years

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
Minimum age
2 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [3] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [4] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
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Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
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Florida
Country [10] 0 0
United States of America
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Georgia
Country [11] 0 0
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Hawaii
Country [12] 0 0
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Idaho
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Illinois
Country [14] 0 0
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Indiana
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Kentucky
Country [16] 0 0
United States of America
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Louisiana
Country [17] 0 0
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Maryland
Country [18] 0 0
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State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
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State/province [20] 0 0
Minnesota
Country [21] 0 0
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State/province [21] 0 0
Mississippi
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
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State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
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State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New Mexico
Country [27] 0 0
United States of America
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New York
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North Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
North Dakota
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United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
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Oregon
Country [33] 0 0
United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
Country [39] 0 0
United States of America
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Washington
Country [40] 0 0
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West Virginia
Country [41] 0 0
United States of America
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Wisconsin
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Manitoba
Country [44] 0 0
Canada
State/province [44] 0 0
Nova Scotia
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Canada
State/province [47] 0 0
Saskatchewan
Country [48] 0 0
New Zealand
State/province [48] 0 0
Auckland
Country [49] 0 0
New Zealand
State/province [49] 0 0
Christchurch
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William B Slayton
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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