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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Japan Adult Leukemia Study Group.
Recruitment status was:  Recruiting
Information provided by:
Japan Adult Leukemia Study Group Identifier:
First received: August 15, 2005
Last updated: November 13, 2008
Last verified: November 2008
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.

Condition Intervention Phase
Lymphoblastic Leukemia, Acute
Drug: Cyclophosphamide
Drug: Daunorubicin
Drug: Vincristine
Drug: Prednisolone
Drug: L-asparaginase
Drug: Cytarabine
Drug: Etoposide
Drug: Dexamethasone
Drug: Methotrexate
Drug: Mercaptopurine
Drug: Doxorubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults

Resource links provided by NLM:

Further study details as provided by Japan Adult Leukemia Study Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ]
  • The rate of complete remission [ Time Frame: 2 months ]

Estimated Enrollment: 240
Study Start Date: September 2002
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Cyclophosphamide Drug: Daunorubicin Drug: Vincristine Drug: Prednisolone Drug: L-asparaginase Drug: Cytarabine Drug: Etoposide Drug: Dexamethasone Drug: Methotrexate
3 g/sqm (high dose)
Drug: Mercaptopurine Drug: Doxorubicin
Active Comparator: B
Drug: Cyclophosphamide Drug: Daunorubicin Drug: Vincristine Drug: Prednisolone Drug: L-asparaginase Drug: Cytarabine Drug: Etoposide Drug: Dexamethasone Drug: Mercaptopurine Drug: Doxorubicin Drug: Methotrexate
0.5 g/sqm (intermediate dose)

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.

Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00131027

Contact: Fumihiko Hayakawa, MD

Department of Hematology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Japan, 466-8550
Contact: Fumihiko Hayakawa, MD   
Principal Investigator: Fumihiko Hayakawa, MD         
Sponsors and Collaborators
Japan Adult Leukemia Study Group
Study Director: Fumihiko Hayakawa, MD Nagoya University
Study Chair: Tomoki Naoe, MD Nagoya University
  More Information

Additional Information: Identifier: NCT00131027     History of Changes
Other Study ID Numbers: JALSG ALL202-O
Study First Received: August 15, 2005
Last Updated: November 13, 2008

Keywords provided by Japan Adult Leukemia Study Group:
acute lymphoblastic leukemia
newly diagnosed

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents processed this record on April 28, 2017