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

This study has been completed.
Sponsor:
Information provided by:
Japan Adult Leukemia Study Group
ClinicalTrials.gov Identifier:
NCT00130195
First received: August 12, 2005
Last updated: November 13, 2008
Last verified: November 2008

August 12, 2005
November 13, 2008
September 2002
February 2008   (final data collection date for primary outcome measure)
The rate of complete remission [ Time Frame: 63 days ] [ Designated as safety issue: No ]
The rate of complete remission
Complete list of historical versions of study NCT00130195 on ClinicalTrials.gov Archive Site
  • The duration of remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity caused by combination of imatinib and chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • The duration of remission
  • Overall survival at one year
  • Toxicity caused by combination of imatinib and chemotherapy
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: imatinib
  • Drug: cyclophosphamide
  • Drug: daunorubicin
  • Drug: vincristine
  • Drug: prednisolone
  • Drug: methotrexate
  • Drug: cytarabine
  • Drug: dexamethasone
Experimental: A
Interventions:
  • Drug: imatinib
  • Drug: cyclophosphamide
  • Drug: daunorubicin
  • Drug: vincristine
  • Drug: prednisolone
  • Drug: methotrexate
  • Drug: cytarabine
  • Drug: dexamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
15 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00130195
JALSG Ph+ALL202
Yes
Not Provided
Japan Adult Leukemia Study Group
Not Provided
Study Director: Fumihiko Hayakawa, MD Nagoya University Graduate School of Medicine
Study Chair: Tomoki Naoe, MD Nagoya University Graduate School of Medicine
Japan Adult Leukemia Study Group
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP