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

Japan Adult Leukemia Study Group

Status and phase: Unknown; Phase 3

Conditions: Lymphoblastic Leukemia, Acute

Treatments: Drug: Etoposide; Drug: Vincristine; Drug: Cytarabine; Drug: Methotrexate; Drug: Cyclophosphamide; Drug: Prednisolone; Drug: Mercaptopurine; Drug: L-asparaginase; Drug: Doxorubicin; Drug: Dexamethasone; Drug: Daunorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00131027

JALSG ALL202-O

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

A

Experimental group

Description:

HD-MTX

Treatment:

Drug: Mercaptopurine

Drug: Etoposide

Drug: Cytarabine

Drug: Prednisolone

Drug: Methotrexate

Drug: Vincristine

Drug: Doxorubicin

Drug: Dexamethasone

Drug: Daunorubicin

Drug: L-asparaginase

Drug: Methotrexate

Drug: Cyclophosphamide

B

Active Comparator group

Description:

ID-MTX

Treatment:

Drug: Mercaptopurine

Drug: Etoposide

Drug: Cytarabine

Drug: Prednisolone

Drug: Methotrexate

Drug: Vincristine

Drug: Doxorubicin

Drug: Dexamethasone

Drug: Daunorubicin

Drug: L-asparaginase

Drug: Methotrexate

Drug: Cyclophosphamide