Trials / Terminated
TerminatedNCT00555048
Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
Detailed description
OBJECTIVES: Primary * Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%. Secondary * Determine the incidence of life-threatening infection in patients receiving this treatment. * Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment. * Determine the survival at 1 year in patients receiving this treatment. * Determine the incidence of disease relapse at 1 year in patients receiving this treatment. * Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment. * Determine the incidence of graft failure at day 100 in patients receiving this treatment. OUTLINE: * Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2. * Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0. * Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11. After completion of study therapy, patients are followed periodically.
Conditions
- Graft Versus Host Disease
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | alemtuzumab | |
| DRUG | busulfan | |
| DRUG | cyclophosphamide | |
| DRUG | methotrexate | |
| DRUG | tacrolimus | |
| PROCEDURE | allogeneic hematopoietic stem cell transplantation | |
| PROCEDURE | peripheral blood stem cell transplantation |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-10-01
- First posted
- 2007-11-07
- Last updated
- 2017-05-24
- Results posted
- 2017-05-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00555048. Inclusion in this directory is not an endorsement.