ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00130195
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
Japan Adult Leukemia Study Group

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 Type : Interventional  (Clinical Trial)
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 : September 2002
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008


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



Primary Outcome Measures :
  1. The rate of complete remission [ Time Frame: 63 days ]

Secondary Outcome Measures :
  1. The duration of remission [ Time Frame: 1 year ]
  2. Overall survival [ Time Frame: 1 year ]
  3. Toxicity caused by combination of imatinib and chemotherapy [ Time Frame: 2 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Study Chair: Tomoki Naoe, MD Nagoya University

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00130195     History of Changes
Other Study ID Numbers: JALSG Ph+ALL202
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisolone
Cyclophosphamide
Methotrexate
Cytarabine
Vincristine
Imatinib Mesylate
Daunorubicin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors