NCT01272817
Completed
Not Applicable
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
ConditionsAplastic AnemiaParoxysmal Nocturnal HemoglobinuriaAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromeChronic Myelogenous LeukemiaChronic Lymphocytic LeukemiaHodgkin's LymphomaNon-Hodgkin's LymphomaMantle Cell LymphomaMultiple MyelomaWaldenstrom MacroglobulinemiaBreast CancerRenal Cell CarcinomaMelanomaSarcomaOvarian CancerThymoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aplastic Anemia
- Sponsor
- Scripps Health
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Engraftment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
Detailed Description
same
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 55 years or
- •Age \< 55 and LVEF \< 45% or creatinine clearance \< 60 ml/min
- •Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
- •Caregiver must be available while outpatient
- •Guidelines for Cladribine-Melphalan-based conditioning:
- •Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
- •AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
- •ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
- •MDS (RAEB, RAEBiT, CMMoL)
- •CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
Exclusion Criteria
- •Prior allogeneic stem cell or bone marrow transplant
- •Current or past history of invasive mycotic infection
- •Breast Feeding
Outcomes
Primary Outcomes
Engraftment
Time Frame: One year
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
Secondary Outcomes
- Graft-versus-host disease(One year)
Study Sites (1)
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