Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: imatinib; Drug: cyclophosphamide; Drug: daunorubicin; Drug: vincristine; Drug: prednisolone; Drug: methotrexate; Drug: cytarabine; Drug: dexamethasone

• Registration Number: NCT00130195
• Lead Sponsor: Japan Adult Leukemia Study Group

Brief Summary

The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Detailed Description

Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Primary Completion: 2008-02
• Study Completion: 2008-05
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Previously untreated BCR-ABL-positive ALL
• Age between 15 and 64 years
• Performance status between 0 and 3 (ECOG criteria)
• Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)
• Written informed consent to participate in the trial

Exclusion Criteria

• Uncontrolled active infection
• Another severe and/or life-threatening disease
• Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
• Another primary malignancy which is clinically active and/or requires medical interventions
• Pregnant and/or lactating women
• Past history of renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	cyclophosphamide	-
A	prednisolone	-
A	cytarabine	-
A	imatinib	-
A	methotrexate	-
A	daunorubicin	-
A	vincristine	-
A	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
The rate of complete remission	63 days

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
Toxicity caused by combination of imatinib and chemotherapy	2 years
The duration of remission	1 year

Trial Locations

Locations (1)

Department of Hematology, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan