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

NCT00130195 | Completed Phase 2 DMC

• 1 other identifier: JALSG Ph+ALL202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The rate of complete remission

  63 days

Secondary Outcomes (3)

• The duration of remission

  1 year

• Overall survival

  1 year

• Toxicity caused by combination of imatinib and chemotherapy

  2 years

Study Arms (1)

A

EXPERIMENTAL

Drug: imatinib; Drug: cyclophosphamide; Drug: daunorubicin; Drug: vincristine; Drug: prednisolone; Drug: methotrexate; Drug: cytarabine; Drug: dexamethasone

Interventions

imatinib DRUG

A

cyclophosphamide DRUG

A

daunorubicin DRUG

A

vincristine DRUG

A

prednisolone DRUG

A

methotrexate DRUG

A

cytarabine DRUG

A

dexamethasone DRUG

A

Eligibility Criteria

• Age: 15 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Adult Leukemia Study Group: lead

Study Sites (1)

Department of Hematology, Nagoya University Graduate School of Medicine

Nagoya, 466-8550, Japan

Location

Related Publications (3)

• Towatari M, Yanada M, Usui N, Takeuchi J, Sugiura I, Takeuchi M, Yagasaki F, Kawai Y, Miyawaki S, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Combination of intensive chemotherapy and imatinib can rapidly induce high-quality complete remission for a majority of patients with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia. Blood. 2004 Dec 1;104(12):3507-12. doi: 10.1182/blood-2004-04-1389. Epub 2004 Aug 17.

  PMID: 15315963 RESULT

• Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Kobayashi T, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Emi N, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. High complete remission rate and promising outcome by combination of imatinib and chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia: a phase II study by the Japan Adult Leukemia Study Group. J Clin Oncol. 2006 Jan 20;24(3):460-6. doi: 10.1200/JCO.2005.03.2177. Epub 2005 Dec 12.

  PMID: 16344315 RESULT

• Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Nishii K, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Narimatsu H, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Karyotype at diagnosis is the major prognostic factor predicting relapse-free survival for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with imatinib-combined chemotherapy. Haematologica. 2008 Feb;93(2):287-90. doi: 10.3324/haematol.11891. Epub 2008 Jan 26.

  PMID: 18223280 RESULT

Related Links

• The JALSG homepage

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Philadelphia Chromosome

Interventions

Imatinib Mesylate; Cyclophosphamide; Daunorubicin; Vincristine; Prednisolone; Methotrexate; Cytarabine; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Translocation, Genetic; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Steroids, Fluorinated

Study Officials

• Fumihiko Hayakawa, MD

  Nagoya University

  STUDY DIRECTOR

• Tomoki Naoe, MD

  Nagoya University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: September 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 14, 2008

Record last verified: 2008-11

Locations

JP (1)