Trials / Unknown
UnknownNCT00328237
Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation
Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- Colorado Blood Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
Detailed description
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine, total body irradiation and cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease. Conditioning Regimen: * Days -10 to -7: Fludarabine 30mg/m2/day IV * Days -7 to -4: TBI 165 centigray BID * Days -3 to -2: Cyclophosphamide 40mg/kg/day IV Day 0: Infusion of Cord Blood Cells Graft-vs-Host Disease Prophylaxis * Day -1: Start tacrolimus 0.03mg/kg/day IV * Day 0: Start MMF 7.5mg/kg IV BID
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myeloid Leukemia
- Non-Hodgkin Lymphoma
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cord Blood Transplant |
Timeline
- Start date
- 2005-11-01
- First posted
- 2006-05-19
- Last updated
- 2006-06-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00328237. Inclusion in this directory is not an endorsement.