Unrelated Donor Transplant for Malignant and Non-Malignant Disorders
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|ClinicalTrials.gov Identifier: NCT01050439|
Recruitment Status : Terminated (PI left the institution)
First Posted : January 15, 2010
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Bone Marrow Failure Syndromes Immunodeficiencies Histiocytosis||Procedure: UDAlloSCT Other: Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unrelated Donor Stem Cell Transplant for Patients With Malignant and Non-Malignant Disorders|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: UDAlloSCT + Therapy
This is a non-randomized study to test the safety and response of unrelated matched donor allogeneic stem cell transplantation (UDAlloSCT) with either myleoablative (full intensity) or reduced intensity conditioning therapy in patients with selected malignant and non-malignant disorders. UDAlloSCT has been performed in both adults and children as an alternative transplant for patients who lack and HLA-matched family donor in both malignant and non-malignant disease with varying degrees of response.
unrelated matched donor allogeneic stem cell transplantation (UDAlloSCT)
Full Intensity Therapy (myeloablative) (TBI + Thiotepa + Cyc) OR Reduced Intensity Therapy (Fludarabine, Busulfan, and Alemutuzumab (FBA))
- Incidence of toxicity related to myeloablative therapy [ Time Frame: Up to 10 years from start of study ]To determine the safety and toxicity of myeloablative therapy (TBI + Melphalan) and unrelated donor alloSCT in selected patients with malignant and non-malignant disorders.
- Incidence of toxicity related to reduced intensity therapy [ Time Frame: Up to 10 years from start of study ]To determine the safety and toxicity of reduced intensity therapy (Fludarabine, Busulfan, and Alemtuzumab (FBA) and unrelated donor alloSCT in selected patients with malignant and non malignant disorders
- Percentage of donor chimerism [ Time Frame: Up to 10 years from start of study ]To quantitate the percentage of donor chimerism following both myeloablative and reduced intensity conditioning and unrelated donor alloSCT in selected patients with malignant and non-malignant disorders.
- Prevalence of progression free survival [ Time Frame: Up to 10 years from start of study ]To estimate the progression free survival (PFS), if applicable, event free survival (EFS) and overall survival (OS) following unrelated donor alloSCT in selected patients with malignant and non malignant disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050439
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Mitchell S Cairo, MD||Columbia University|