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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fludarabine; Fludarabine phosphate; Thiotepa

Criteria

Inclusion Criteria:

• Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome

• HLA 6/6 or 5/6 antigen matched related or unrelated donor

• creatinine = normal or if not, CrCl > 60 ml/min/1.73ml

• total bilirubin < 2.5, AST < 2xnl, cardiac function > 50%

• pulmonary function - asymptomatic or if not DLCO > %50% (corrected for Hgb)

• Karnofsky performance status > 70%

• negative pregnancy test (where applicable)

• signed informed consent of patient and donor.

Exclusion Criteria:

• Pregnancy or lactation

• unwillingness to comply with protocol treatment or follow-up

• uncontrolled infection

• HIV or HTLV positivity

• active CNS/skin disease