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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Japan Adult Leukemia Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Japan Adult Leukemia Study Group
ClinicalTrials.gov Identifier:
NCT00131027
First received: August 15, 2005
Last updated: November 13, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • The rate of complete remission [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
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)

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.

  Eligibility

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Graduate School of Medicine
Study Chair: Tomoki Naoe, MD Nagoya University Graduate School of Medicine
  More Information

Additional Information:
The JALSG homepage  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00131027     History of Changes
Other Study ID Numbers: JALSG ALL202-O
Study First Received: August 15, 2005
Last Updated: November 13, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
6-Mercaptopurine
Cytarabine
Methotrexate
 Cyclophosphamide
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Etoposide
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
BB 1101
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Dexamethasone 21-phosphate

ClinicalTrials.gov processed this record on May 19, 2013