Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia (FluTBI)
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|ClinicalTrials.gov Identifier: NCT01991457|
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adult Lymphoblastic Lymphoma||Drug: Fludarabine Procedure: Total Body Irradiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen|
|Actual Study Start Date :||August 27, 2013|
|Estimated Primary Completion Date :||December 28, 2021|
|Estimated Study Completion Date :||December 2022|
Fludarabine, Total Body Irradiation (TBI)
Procedure: Total Body Irradiation
- Number of subjects Disease-free survival [ Time Frame: 2 years post-transplant ]
- Number of subjects that survived [ Time Frame: 2 years post-transplant ]
- Number of subjects with neutrophil engraftment [ Time Frame: Within the first 100 days ]Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) > 500/μL.
- Number of subjects with regimen related toxicity [ Time Frame: Within first 100 days post-transplant ]
- Number of subjects with Acute GVHD [ Time Frame: 2 years post transplant ]
- Mean rate of Immune Reconstitution [ Time Frame: 1 year post transplant ]Track the growth rate of and the number of lymphocyte subsets.
- Number of subjects with relapse [ Time Frame: 2 Years post-transplant ]
- Number of subjects with platelet engraftment [ Time Frame: Within 100 days post transplant ]Platelet engraftment is defined as the first of 3 consecutive days with a platelet count > 20,000/μL without platelet transfusion for 7 days.
- Number of subjects with chronic GVHD [ Time Frame: 2 years post transplant ]
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): NCT01991457
|United States, Alabama|
|UAB Bone Marrow Transplantation and Cellular Therapy Program|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Donna E Salzman, MD||University of Alabama at Birmingham|