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

Completed · Phase 2

Conditions studied: Allogeneic Stem Cell Transplant, Leukemia, Non-Hodgkins, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, Paroxysmal Nocturnal Hemoglobinuria (PNH)

In brief

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.

Key facts

Study ID

NCT00587054

Run by

Memorial Sloan Kettering Cancer Center

People needed

129

Starts

2001-06-01

Expected to finish

2011-05-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnancy or lactation
• unwillingness to comply with protocol treatment or follow-up
• uncontrolled infection
• HIV or HTLV positivity
• active CNS/skin disease

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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