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


Phase 2
15 Years
64 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The rate of complete remission

Outcome Time Frame:

63 days

Safety Issue:

No

Principal Investigator

Fumihiko Hayakawa, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nagoya University Graduate School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JALSG Ph+ALL202

NCT ID:

NCT00130195

Start Date:

September 2002

Completion Date:

May 2008

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • acute lymphoblastic leukemia
  • BCR-ABL
  • Philadelphia-chromosome
  • newly diagnosed
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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