Phase 2
N=129
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
Allogeneic Stem Cell Transplant · Leukemia · Non-Hodgkins · Lymphoblastic Lymphoma · Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00587054 ↗Enrolled (actual)
129
Serious AEs
10.1%
Results posted
Mar 2017
Primary outcome: Primary: Overall Survival of Transplant Patients — 727.5 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival of Transplant Patients |
727.5 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00587054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.