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| Sponsored by: |
Japan Adult Leukemia Study Group |
| Information provided by: | Japan Adult Leukemia Study Group |
| ClinicalTrials.gov Identifier: | NCT00131053 |
Purpose
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
| Condition | Intervention | Phase |
|
Lymphoblastic Leukemia, Acute |
Drug: Methotrexate Drug: Prednisolone Drug: Dexamethasone Drug: Vincristine Drug: Pirarubicin Drug: Cyclophosphamide Drug: L-asparaginase Drug: Cytarabine Drug: Hydrocortisone Drug: Mercaptopurine |
Phase II |
| MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental | Drug: Methotrexate Drug: Prednisolone Drug: Dexamethasone Drug: Vincristine Drug: Pirarubicin Drug: Cyclophosphamide Drug: L-asparaginase Drug: Cytarabine Drug: Hydrocortisone Drug: Mercaptopurine |
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.
Eligibility
| Ages Eligible for Study: | 15 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Masamitsu Yanada, MD | myanada@med.nagoya-u.ac.jp |
| Japan | |||||
| Department of Hematology, Nagoya University Graduate School of Medicine | Recruiting | ||||
| Nagoya, Japan, 466-8550 | |||||
| Contact: Masamitsu Yanada, MD myanada@med.nagoya-u.ac.jp | |||||
| Principal Investigator: Masamitsu Yanada, MD | |||||
| Japan Adult Leukemia Study Group |
| Study Director: | Masamitsu Yanada, MD | Nagoya University Graduate School of Medicine |
| Study Chair: | Tomoki Naoe, MD | Nagoya University Graduate School of Medicine |
More Information
The JALSG homepage
|
| Study ID Numbers: | JALSG ALL202-U |
| First Received: | August 15, 2005 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00131053 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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