Trials / Unknown
UnknownNCT00304720
Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor
Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Colorado Blood Cancer Institute · Academic / Other
- Sex
- All
- Age
- 50 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF. B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
Detailed description
Conditioning regimen: 1. Days - 4 to -2: Fludarabine 30 mg/m2/day IV. 2. Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration. Immunosuppression: Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).
Conditions
- Multiple Myeloma
- Lymphoma
- Acute Myelogenous Leukemia
- Acute Lymphocytic Leukemia
- Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus and MMF |
Timeline
- Start date
- 2004-03-01
- First posted
- 2006-03-20
- Last updated
- 2008-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00304720. Inclusion in this directory is not an endorsement.