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

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ClinicalTrials.gov Identifier: NCT00131027
Recruitment Status : Unknown
Verified November 2008 by Japan Adult Leukemia Study Group.
Recruitment status was:  Recruiting
First Posted : August 17, 2005
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2002
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : September 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: A
HD-MTX
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
ID-MTX
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)


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131027


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

Locations
Japan
Department of Hematology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Japan, 466-8550
Contact: Fumihiko Hayakawa, MD       bun-hy@med.nagoya-u.ac.jp   
Principal Investigator: Fumihiko Hayakawa, MD         
Sponsors and Collaborators
Japan Adult Leukemia Study Group
Investigators
Study Director: Fumihiko Hayakawa, MD Nagoya University
Study Chair: Tomoki Naoe, MD Nagoya University
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00131027     History of Changes
Other Study ID Numbers: JALSG ALL202-O
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Japan Adult Leukemia Study Group:
acute lymphoblastic leukemia
newly diagnosed
BCR-ABL-negative

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisolone
Cyclophosphamide
Doxorubicin
Methotrexate
Etoposide
Cytarabine
Vincristine
Daunorubicin
Asparaginase
6-Mercaptopurine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal