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

November 13, 2008 updated by: Japan Adult Leukemia Study Group

Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Nagoya, Japan, 466-8550
        • Recruiting
        • Department of Hematology, Nagoya University Graduate School of Medicine
        • Contact:
        • Principal Investigator:
          • Fumihiko Hayakawa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
HD-MTX
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Prednisolone
Drug: Cytarabine
Drug: Etoposide
Drug: Daunorubicin
Drug: L-asparaginase
Drug: Methotrexate
3 g/sqm (high dose)
Drug: Mercaptopurine
Drug: Methotrexate
0.5 g/sqm (intermediate dose)
Active Comparator: B
ID-MTX
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Prednisolone
Drug: Cytarabine
Drug: Etoposide
Drug: Daunorubicin
Drug: L-asparaginase
Drug: Methotrexate
3 g/sqm (high dose)
Drug: Mercaptopurine
Drug: Methotrexate
0.5 g/sqm (intermediate dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 2 years
2 years
The rate of complete remission
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Adult Leukemia Study Group

Investigators

  • Study Director: Fumihiko Hayakawa, MD, Nagoya University
  • Study Chair: Tomoki Naoe, MD, Nagoya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 17, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 13, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JALSG ALL202-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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