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

NCT ID: NCT00130195

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Lymphoblastic Leukemia

Keywords

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acute lymphoblastic leukemia BCR-ABL Philadelphia-chromosome newly diagnosed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

imatinib

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

daunorubicin

Intervention Type DRUG

vincristine

Intervention Type DRUG

prednisolone

Intervention Type DRUG

methotrexate

Intervention Type DRUG

cytarabine

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

Interventions

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imatinib

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

daunorubicin

Intervention Type DRUG

vincristine

Intervention Type DRUG

prednisolone

Intervention Type DRUG

methotrexate

Intervention Type DRUG

cytarabine

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Adult Leukemia Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Fumihiko Hayakawa, MD

Role: STUDY_DIRECTOR

Nagoya University

Tomoki Naoe, MD

Role: STUDY_CHAIR

Nagoya University

Locations

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Department of Hematology, Nagoya University Graduate School of Medicine

Nagoya, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 15315963 (View on PubMed)

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.

Reference Type RESULT
PMID: 16344315 (View on PubMed)

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.

Reference Type RESULT
PMID: 18223280 (View on PubMed)

Related Links

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http://www.jalsg.jp/

The JALSG homepage

Other Identifiers

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JALSG Ph+ALL202

Identifier Type: -

Identifier Source: org_study_id