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

Lymphoblastic Leukemia, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00131027
• Other study ID #: JALSG ALL202-O
• Status: Recruiting
• Phase: Phase 3
• First received: August 15, 2005
• Last updated: November 13, 2008
• Start date: September 2002
• Est. completion date: September 2011

Study information

• Verified date: November 2008
• Source: Japan Adult Leukemia Study Group
• Contact: Fumihiko Hayakawa, MD
• Email: bun-hy[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Cyclophosphamide

• Daunorubicin

• Vincristine

• Prednisolone

• L-asparaginase

• Cytarabine

• Etoposide

• Dexamethasone

• Methotrexate
3 g/sqm (high dose)
• Mercaptopurine

• Doxorubicin

• Methotrexate
0.5 g/sqm (intermediate dose)

Locations

Country	Name	City	State
Japan	Department of Hematology, Nagoya University Graduate School of Medicine	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Japan Adult Leukemia Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years	No
Secondary	Toxicity		2 years	Yes
Secondary	The rate of complete remission		2 months	No

External Links

•   The JALSG homepage