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High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

NCT ID: NCT00131027

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

Detailed Description

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Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.

Conditions

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Lymphoblastic Leukemia, Acute

Keywords

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acute lymphoblastic leukemia newly diagnosed BCR-ABL-negative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

ID-MTX

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

L-asparaginase

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

0.5 g/sqm (intermediate dose)

A

HD-MTX

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

L-asparaginase

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

3 g/sqm (high dose)

Mercaptopurine

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Interventions

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Cyclophosphamide

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

L-asparaginase

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Methotrexate

3 g/sqm (high dose)

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Methotrexate

0.5 g/sqm (intermediate dose)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previously untreated BCR-ABL-negative ALL
* Age between 25 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

25 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 RECRUITING

Countries

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Japan

Central Contacts

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Fumihiko Hayakawa, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fumihiko Hayakawa, MD

Role: primary

Related Links

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http://www.jalsg.jp/

The JALSG homepage

Other Identifiers

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JALSG ALL202-O

Identifier Type: -

Identifier Source: org_study_id