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

• Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL); MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022946-25-Outside-EU/EEA
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

DISEASE CHARACTERISTICS:
•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 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 DFCI Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
•Received the first 2 weeks of induction therapy prior to study enrollment
?Patients may NOT have received day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial)
•No Down syndrome
PATIENT CHARACTERISTICS:
•Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
•Lansky PS 50-100% (for patients = 16 years of age)
•Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min 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)
•ALT < 2.5 times ULN
•Shortening fraction = 27% by echocardiogram OR LVEF = 50% by gated radionuclide study
•QTc = 0.45 seconds by EKG
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception
•No evidence of dyspnea at rest
•No exercise intolerance
•Pulse oximetry > 94% at sea level (if there is a clinical indication for determination)
•Seizure disorder allowed provided it is well controlled on anticonvulsants
PRIOR CONCURRENT THERAPY:
•No other concurrent cancer chemotherapy or immunomodulatory agents (including steroids)
Are the trial subjects under 18? yes
Number of subjects for this age range: 58
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 QTc greater than 0.45 seconds. Patients must have an EKG fewer than 6 days prior to enrollment onto AALL0622.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified