Unrelated Donor Transplant for Malignant and Non-Malignant Disorders
Stopped early · Phase 2
Conditions studied: Leukemia, Lymphoma, Bone Marrow Failure Syndromes, Immunodeficiencies, Histiocytosis
In brief
Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell transplantation (UDAlloSCT) with either myeloablative or reduced intensity conditioning will be well tolerated and result in a high degree of engraftment in patients with selected malignant and non malignant disorders.
Key facts
- Study ID
- NCT01050439
- Run by
- Columbia University
- People needed
- 22
- Starts
- 2002-11-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2015-04-15
Who can join
Age: any, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adequate renal function defined as: serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or > 40 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range.
- Adequate liver function defined as: total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal.
- Adequate cardiac function defined as: shortening fraction of > 25% by echocardiogram, or ejection fraction of > 40% by radionuclide angiogram or echocardiogram.
- Adequate pulmonary function defined as: DLCO > 35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% in room air.
- Diseases:
- CML (CP, AP or BC)
- AML/MDS/JCML
- ALL
- Lymphoma (Hodgkin's and non-Hodgkin's)
- Non-malignant disorders
- Bone Marrow Failure Syndromes: Patients with the following diagnoses are eligible:
- Severe Aplastic Anemia:
- Fanconi Anemia
- Severe Congenital Neutropenia (Kostmann's Syndrome)
- Amegakaryocytic Thrombocytopenia
- Diamond-Blackfan Anemia
- Infantile Osteopetrosis
- Schwachman-Diamond Syndrome
- Dyskeratosis Congenita
- Other bone marrow failure syndromes at discretion of Principal Investigator
- Immunodeficiencies:
- SCIDS, all subtypes
- Combined Immunodeficiency Syndrome
- Wiskott-Aldrich syndrome
- Chronic Granulomatous Disease
You may not qualify if…
- Women who are pregnant and/or breast feeding are ineligible
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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