Double Cord Versus Haploidentical (BMT CTN 1101)

PHASE3CompletedINTERVENTIONAL
Enrollment

368

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

September 11, 2020

Study Completion Date

September 11, 2020

Conditions
Acute Lymphocytic LeukemiaAcute Myelogenous LeukemiaBurkitt's LymphomaFollicular LymphomaHodgkin LymphomaMantle Cell LymphomaNon-Hodgkin Lymphoma
Interventions
BIOLOGICAL

Haploidentical Bone Marrow Transplant

"The conditioning regimen consists of:~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2 Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5 Total body irradiation (TBI) 200cGy Day -1~The GVHD prophylaxis regimen consists of:~Cy 50 mg/kg IV Days 3, 4 Tacrolimus (IV or PO) beginning Day 5 Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35"

BIOLOGICAL

Double Umbilical Cord Blood Transplant

"The preparative regimen consists of:~Fludarabine 40 mg/m2 IV Days -6, -5, -4,-3, -2 Cyclophosphamide 50 mg/kg IV Day -6 Total Body Irradiation (TBI) 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the 3 months of enrollment or an autologous transplant within 24 months of enrollment or 300 cGy Day -1 for patients who have not received cytotoxic chemotherapy within the 3 months of enrollment and who have not received an autologous transplant within 24 months of enrollment.~The GVHD prophylaxis regimen consists of:~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL.~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day -3 until Day 35"

Trial Locations (39)

10029

Mt. Sinai Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

14203

Roswell Park Cancer Center, Buffalo

14642

University of Rochester Medical Center, Rochester

17033

Penn State College of Medicine - The Milton S. Hershey Medical Center, Hershey

19104

University of Pennsylvania Cancer Center, Philadelphia

21231

Johns Hopkins University, Baltimore

23298

Virginia Commonwealth University, Richmond

27705

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

30342

BMT Program at Northside Hospital, Atlanta

32804

Florida Hospital Cancer Institute, Orlando

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

43210

Ohio State / Arthur G. James Cancer Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45236

Jewish Hospital BMT Program, Cincinnati

48109

University of Michigan Medical Center, Ann Arbor

48201

Karmanos Cancer Institute/BMT, Detroit

53211

Medical College of Wisconsin, Milwaukee

55455

Univeristy of Minnesota, Minneapolis

55905

Mayo Clinic Rochester, Rochester

66160

University of Kansas Hospital, Kansas City

73104

University of Oklahoma Medical Center, Oklahoma City

77030

Univesity of Texas, MD Anderson CRC, Houston

78229

Texas Transplant Institute, San Antonio

85013

Arizona Cancer Center, Phoenix

90095

University of California at Los Angeles, Los Angeles

94305

Stanford Hospital and Clinics, Stanford

91010-3000

City of Hope National Medical Center, Duarte

32610-0277

University of Florida College of Medicine (Shands), Gainesville

02114

DFCI Massachustts General Hospital, Boston

02115

DFCI Brigham & Women's Hospital, Boston

11794-7122

Stony Brook University Medical Center, Stony Brook

27599-7305

University of North Carolina Hospital at Chapel Hill, Chapel Hill

44106-5061

University Hospitals of Cleveland, Case Western, Cleveland

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

26506-9162

West Virginia University, Morgantown

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Marrow Donor Program

OTHER

lead

Medical College of Wisconsin

OTHER

NCT01597778 - Double Cord Versus Haploidentical (BMT CTN 1101) | Biotech Hunter | Biotech Hunter