Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases
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|ClinicalTrials.gov Identifier: NCT02145039|
Recruitment Status : Terminated (Replaced by another study.)
First Posted : May 22, 2014
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemias Burkitt's Lymphoma Chronic Myelogenous Leukemia||Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total Body Irradiation Biological: Haploidentical stem cell transplant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduced Intensity Conditioning (RIC) and Transplantation of HLA(Human Leukocyte Antigen)-Haploidentical Related Bone Marrow (Haplo-BM) For Patients With Hematologic Diseases|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2019|
Experimental: Haploidentical stem cell transplant
This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI).
Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.
Other Name: Fludara
Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.
Radiation: Total Body Irradiation
TBI 200cGy on day -1 before transplant.
Other Name: TBI
Biological: Haploidentical stem cell transplant
Non-T-cell depleted bone marrow infusion
Other Name: HSCT
- 2 Year Survival [ Time Frame: 2 years ]Percentage of patients that survive 2 years post-transplant
- Number of Patients With Hematopoietic Engraftment [ Time Frame: 42 days ]Engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10^8/L for 3 consecutive measurements.
- Number of Patients With Chimerism [ Time Frame: 100 days ]Number of patients with chimerism at day 100, 6 months and 1 year
- Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days [ Time Frame: 100 days ]
- Number of Patients Experiencing Chronic Graft-versus-host Disease by 1 Year [ Time Frame: 1 year ]
- Number of Patients Experiencing Transplant Related Mortality (TRM) [ Time Frame: 6 months ]
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): NCT02145039
|United States, Minnesota|
|University of Minnesota Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Claudio Brunstein, MD||University of Minnesota|