Trials / Completed
CompletedNCT00185796
TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD
Total Lymphoid Irradiation and Anti-Thymocyte Globulin as Conditioning for Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for the Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 49 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients with advanced stage MDS and MPD.
Detailed description
Total Lymphoid Irradiation and Anti-Thymocyte Globulin as Conditioning for Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for the Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (except CML). To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients or those with co-morbid conditions that preclude myeloablative transplantation for advanced stage MDS and MPD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Total Lymphoid Irradiation (TLI) | TLI is administered ten times in 120cGy fractions on day -11 through day -7 and day -4 through day -1 |
| PROCEDURE | Anti-Thymocyte Globulin as Conditioning (ATG) | Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg. Thymoglobulin doses will be based on the adjusted ideal body weight if the patient is greater than or equal to 15 kg over ideal body weight. |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2014-04-01
- Completion
- 2015-02-01
- First posted
- 2005-09-16
- Last updated
- 2015-03-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00185796. Inclusion in this directory is not an endorsement.