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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130195

Enrollment

100

Registered

2005-08-15

Start date

2002-09-30

Completion date

2008-05-31

Last updated

2008-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia, BCR-ABL, Philadelphia-chromosome, newly diagnosed

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.

Interventions

DRUGimatinib

DRUGcyclophosphamide

DRUGdaunorubicin

DRUGvincristine

DRUGprednisolone

DRUGmethotrexate

DRUGcytarabine

DRUGdexamethasone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
The rate of complete remission	63 days

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026