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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 25 to 65 Other JALSG ALL202-O
NCT00131027

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Japan Adult Leukemia Study Group

Fumihiko Hayakawa, MD

Study Director

Tomoki Naoe, MD

Study Chair

Fumihiko Hayakawa, MD
		Email: bun-hy@med.nagoya-u.ac.jp

Trial Sites

Japan

Nagoya

Nagoya University School of Medicine

Fumihiko Hayakawa, MD

Email: bun-hy@med.nagoya-u.ac.jp

Fumihiko Hayakawa, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00131027
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.