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

Sponsor

Japan Adult Leukemia Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00130195

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: imatinib Drug: cyclophosphamide Drug: daunorubicin Drug: vincristine Drug: prednisolone Drug: methotrexate Drug: cytarabine Drug: dexamethasone	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: imatinib Drug: cyclophosphamide Drug: daunorubicin Drug: vincristine Drug: prednisolone Drug: methotrexate Drug: cytarabine Drug: dexamethasone

Arm

Intervention/Treatment

Experimental: A

Drug: imatinib

Drug: cyclophosphamide

Drug: daunorubicin

Drug: vincristine

Drug: prednisolone

Drug: methotrexate

Drug: cytarabine

Drug: dexamethasone

Outcome Measures

Primary Outcome Measures

The rate of complete remission [63 days]

Secondary Outcome Measures

The duration of remission [1 year]
Overall survival [1 year]
Toxicity caused by combination of imatinib and chemotherapy [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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