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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00131027

Enrollment

240

Registered

2005-08-17

Start date

2002-09-30

Completion date

2011-09-30

Last updated

2008-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoblastic Leukemia, Acute

Keywords

acute lymphoblastic leukemia, newly diagnosed, BCR-ABL-negative

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.

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.

Interventions

DRUGCyclophosphamide

DRUGDaunorubicin

DRUGVincristine

DRUGPrednisolone

DRUGL-asparaginase

DRUGCytarabine

DRUGEtoposide

DRUGDexamethasone

DRUGMethotrexate

3 g/sqm (high dose)

DRUGMercaptopurine

DRUGDoxorubicin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
Disease-free survival	3 years

Secondary

Measure	Time frame
The rate of complete remission	2 months
Toxicity	2 years

Countries

Japan

Contacts

Primary ContactFumihiko Hayakawa, MD

bun-hy@med.nagoya-u.ac.jp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026