Northside Hospital
Atlanta, Georgia, 30342, United States
NCT Number: NCT02581007
This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Atlanta, Georgia, 30342, United States
Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 & 4 post-transplant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;
Other names: Fludara
Other names: melphalan (140mg/m2) given one time on Day -1.
cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
Other names: Cytoxan
Other names: HSCT
Time frame: 100 days
Measurement of donor cells vs. recipient cells
Time frame: 2 years
Number of participants still alive 2 years after transplant
Time frame: 2 years
Number of patients with disease reoccurrence at 1 and 2 years post-transplant
Time frame: 100 days
The number of participants that developed graft-versus-host-disease before or at 100 days after transplant
Northside Hospital, Inc.
Other
Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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