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
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Drug: imatinib
Drug: cyclophosphamide
Drug: daunorubicin
Drug: vincristine
Drug: prednisolone
Drug: methotrexate
Drug: cytarabine
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Japan Adult Leukemia Study Group:

Primary Outcome Measures:
  • The rate of complete remission [ Time Frame: 63 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: September 2002
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: imatinib Drug: cyclophosphamide Drug: daunorubicin Drug: vincristine Drug: prednisolone Drug: methotrexate Drug: cytarabine Drug: dexamethasone

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.

  Eligibility

Ages Eligible for Study:   15 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130195

Locations
Japan
Department of Hematology, Nagoya University Graduate School of Medicine
Nagoya, Japan, 466-8550
Sponsors and Collaborators
Japan Adult Leukemia Study Group
Investigators
Study Director: Fumihiko Hayakawa, MD Nagoya University Graduate School of Medicine
Study Chair: Tomoki Naoe, MD Nagoya University Graduate School of Medicine
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00130195     History of Changes
Other Study ID Numbers: JALSG Ph+ALL202
Study First Received: August 12, 2005
Last Updated: November 13, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Adult Leukemia Study Group:
acute lymphoblastic leukemia
BCR-ABL
Philadelphia-chromosome
newly diagnosed

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Imatinib
Daunorubicin
Dexamethasone
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
BB 1101
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014