Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

PHASE2CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

June 30, 2001

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Allogeneic Stem Cell TransplantLeukemiaNon-HodgkinsLymphoblastic LymphomaMyelodysplastic SyndromeParoxysmal Nocturnal Hemoglobinuria (PNH)
Interventions
DRUG

cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant

"Myeloablative and will consist of hyperfractionated TBI - 1375 cGy administered in 11 doses of 125 cGy each over a total of four days, with three doses on three days and two doses on the last day, fludarabine 25 mg/m2 IV x 5 days, and thiotepa 5mg/kg IV x 2 days. Recipients of HLA identical related transplants will not receive ATG to promote engraftment. Recipients of HLA mismatched related or unrelated stem cells will receive ATG for two days prior to the transplant. G-CSF mobilized CD34+E- PBSCs obtained from the HLA compatible donor will be infused on day 0. Post transplantation G-CSF will be administered only if clinically indicated and should begin on or after d+7.~Patients will be clinically evaluated at each clinic visit for incidence and severity of acute and chronic GVHD and transplant associated morbidity. Sequential evaluation of functional reconstitution of hematopoiesis and immunity will be made as per the BMT Service guidelines."

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00587054 - Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders | Biotech Hunter | Biotech Hunter