Trials / Completed
CompletedNCT00270881
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Keio University · Academic / Other
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.
Detailed description
Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.
Conditions
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cord blood transplantation | unrelated cord blood transplantation |
| RADIATION | TBI | Total body irradiation (TBI) 12Gy |
| DRUG | cyclophosphamide | cyclophosphamide 120mg/kg |
| DRUG | cytarabine | cytarabine 3g/m2x4 |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-01-01
- Completion
- 2011-01-01
- First posted
- 2005-12-29
- Last updated
- 2012-04-06
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00270881. Inclusion in this directory is not an endorsement.