At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed acute or chronic leukemia, non-Hodgkin lymphoma, lymphoblastic lymphoma, or myelodysplastic syndrome
- ✓HLA 6/6 or 5/6 antigen matched related or unrelated donor available
- ✓Creatinine normal or CrCl >60 ml/min/1.73ml if elevated
- ✓Total bilirubin <2.5, AST <2x normal, cardiac function >50%
- ✕Pregnancy or lactation
- ✕Unwillingness to comply with protocol treatment or follow-up
- ✕Uncontrolled infection
- ✕HIV or HTLV positivity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders
In Brief
A Phase 2 clinical trial evaluating cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant for Allogeneic Stem Cell Transplant and 5 related conditions. Completed, enrolled 129 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.