Phase II Feasibility Study of T-Cell Depletion in Allogeneic Unrelated Bone Marrow Transplantation (MUD ALLO BMT) Followed by Delayed T-Cell Infusions
- Determine if T-cell depletion of a peripheral blood progenitor cell (PBPC) graft
followed by delayed add-backs of defined doses of donor lymphocytes decreases the rate
of graft-versus-host disease and its complications in matched unrelated donor (MUD)
allogeneic PBPC transplantation in patients with hematologic cancers or other diseases.
- Determine whether targeted T-cell dosages in the PBPC graft can be achieved in these
patients by positive CD34+ selection using the Baxter Inc. Isolex 300i v. 2.5.
- Determine the effects of T-cell depletion on the rate of engraftment in these patients.
- Develop a MUD allogeneic transplantation regimen that will decrease overall
treatment-related mortality in these patients.
OUTLINE: This is a non-randomized study.
- Myeloablative preparative regimen: Patients receive cyclophosphamide IV once daily on
days -5 and -4 followed by total body irradiation twice daily on days -3, -2, and -1.
Patients also receive tacrolimus on day -1 administered by continuous IV infusion over
- Peripheral blood progenitor cell graft transplantation: Patients receive T-cell
depleted, peripheral blood progenitor cells (PBPC) by IV infusion on day 0. Beginning 1
day after completion of the PBPC infusion, patients receive filgrastim (G-CSF)
subcutaneously once daily until blood counts recover.
- Post transplantation T cell add-backs: Patients receive defined doses of donor T cells
by IV infusion on days 45 and 100, in the absence of active graft-versus-host disease
(GVHD) requiring steroids*.
NOTE: *A T cell add-back may be given in the presence of GVHD, if the investigator considers
the risk from relapse or overwhelming viral infection to outweigh the risk of exacerbating
Patients will be followed periodically for relapse and survival.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality (TRM)
Brian J. Bolwell, MD
The Cleveland Clinic
United States: Federal Government
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