60
Participants
Start Date
May 12, 2025
Primary Completion Date
August 1, 2028
Study Completion Date
February 1, 2029
Haploidentical donor bone marrow transplant
"Drugs:~1. Antithymocyte Globulin (ATG) dose will be 0.5 mg/kg IV on Day -9 over 6 hours and 2 mg/kg IV on Days -8 and -7 over 4 hours.~2. Fludarabine dose will be 30 mg/m\^2 IV daily for 5 days from Day -6 to Day -2.~3. Cyclophosphamide dose will be 14.5 mg/kg IV daily for 2 days (Day -6 to Day -5) prior to transplantation and 50 mg/kg IV daily for 2 days (Day +3 to Day +4) after transplantation.~4. Tacrolimus should be started on Day +5 and administered to maintain a level of 10-15 ng/mL.~5. Mycophenolate mofetil (MMF) dose will be 15 mg/kg PO three times a day (TID) up to 1 gm TID (or IV equivalent) starting on Day +5 through Day +35.~6. G-CSF will be given IV or SQ starting on Day +5 at 5 mcg/kg/day until ANC is \> 1500 for 3 days.~Radiation:~1\. Total Body Irradiation (TBI): will be given as a single dose of 400 cGy on Day -1.~Procedure:~1\. HSCT: Eligible patients will receive a haploidentical donor bone marrow transplant."
Unrelated donor bone marrow transplant
"Drugs:~1. Antithymocyte Globulin (ATG) dose will be 0.5 mg/kg IV on Day -9 over 6 hours and 2 mg/kg IV on Days -8 and -7 over 4 hours.~2. Fludarabine dose will be 30 mg/m\^2 IV daily for 5 days from Day -6 to Day -2.~3. Cyclophosphamide dose will be 14.5 mg/kg IV daily for 2 days (Day -6 to Day -5) prior to transplantation and 50 mg/kg IV daily for 2 days (Day +3 to Day +4) after transplantation.~4. Tacrolimus should be started on Day +5 and administered to maintain a level of 10-15 ng/mL.~5. Mycophenolate mofetil (MMF) dose will be 15 mg/kg PO three times a day (TID) up to 1 gm TID (or IV equivalent) starting on Day +5 through Day +35.~6. G-CSF will be given IV or SQ starting on Day +5 at 5 mcg/kg/day until ANC is \> 1500 for 3 days.~Radiation:~1\. Total Body Irradiation (TBI): will be given as a single dose of 400 cGy on Day -1.~Procedure:~1\. HSCT: Eligible patients will receive an unrelated donor bone marrow transplant."
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
University of Pennsylvania, Philadelphia
RECRUITING
Johns Hopkins University, Baltimore
RECRUITING
UNC Chapel Hill, Chapel Hill
RECRUITING
Duke University Health System, Durham
RECRUITING
Levine Cancer Institute, Charlotte
NOT_YET_RECRUITING
Emory Winship Cancer Institute, Atlanta
RECRUITING
Blood and Marrow Transplant Center at Northside Hospital, Atlanta
RECRUITING
Moffitt Cancer Center, Tampa
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
Vanderbilt University, Nashville
RECRUITING
The Ohio State University, Columbus
RECRUITING
Karmanos Cancer Institute, Detroit
RECRUITING
Medical College of Wisconsin, Milwaukee
NOT_YET_RECRUITING
Mayo Clinic, Rochester
RECRUITING
Washington University School of Medicine, Barnes-Jewish Hospital, St Louis
RECRUITING
University of Kansas Medical Center, Westwood
NOT_YET_RECRUITING
University of Oklahoma, Oklahoma City
NOT_YET_RECRUITING
Huntsman Cancer Institute, Salt Lake City
NOT_YET_RECRUITING
University of California, Los Angeles, Los Angeles
RECRUITING
City of Hope, Duarte
RECRUITING
Stanford University, Stanford
RECRUITING
Fred Hutchinson Cancer Center, Seattle
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Dana Farber Cancer Institute, Boston
Collaborators (1)
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Sanofi
INDUSTRY
Medical College of Wisconsin
OTHER