Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies

Summary

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.

Arms & interventions

• DrugFludarabine

  Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

• DrugBusulfan

  Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5

• DrugMelphalan

  Melphalan 50 mg/m2 IV on days -4 to -2

• DrugRituximab

  200 mg/m2 intravenous given once on day-1

• DrugLevetiracetam

  As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

• BiologicalAlpha/Beta T Cell-Depleted Hematopoietic Stem Cells

  Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

• DrugThymoglobulin

  rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.

• DrugCyclophosphamide

  Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Outcome measures

Eligibility criteria