High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)
NCT00131027 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2008-11-14
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.
Conditions
- Lymphoblastic Leukemia, Acute
Interventions
- DRUG
- DRUG
-
Daunorubicin
- DRUG
-
Vincristine
- DRUG
-
Prednisolone
- DRUG
-
L-asparaginase
- DRUG
- DRUG
-
Etoposide
- DRUG
- DRUG
-
Methotrexate
3 g/sqm (high dose)
- DRUG
-
Mercaptopurine
- DRUG
-
Doxorubicin
- DRUG
-
Methotrexate
0.5 g/sqm (intermediate dose)
Sponsors & Collaborators
-
Japan Adult Leukemia Study Group
lead OTHER
Principal Investigators
-
Fumihiko Hayakawa, MD · Nagoya University
-
Tomoki Naoe, MD · Nagoya University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-09-30
- Primary Completion
- 2011-03-31
- Completion
- 2011-09-30
Countries
- Japan
Study Locations
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