Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
| Status: | Available |
|---|---|
| Conditions: | Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 7/20/2018 |
| Contact: | Paolo Caimi, MD |
| Email: | paolo.caimi@uhhospitals.org |
| Phone: | 216-844-8220 |
This clinical trial studies the use of a second infusion of donor hematopoietic cells that
have had removal of T cells for the treatment of engraftment failure after a first
hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete
failure of recovery of blood counts. This results in frequent needs for transfusions and
other methods to maintain blood counts at acceptable levels. One way of improving the blood
counts in the recipient is to give a "booster" dose of cells from the donor, but this is
associated with increased risk of an immune reaction from the donor cells against the
recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,
responsible for this type of immune reaction. These cells are removed by a special handling
of the graft, which allows to remove the cells directly or indirectly (by selecting other
cells to "stay" in the graft").
have had removal of T cells for the treatment of engraftment failure after a first
hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete
failure of recovery of blood counts. This results in frequent needs for transfusions and
other methods to maintain blood counts at acceptable levels. One way of improving the blood
counts in the recipient is to give a "booster" dose of cells from the donor, but this is
associated with increased risk of an immune reaction from the donor cells against the
recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,
responsible for this type of immune reaction. These cells are removed by a special handling
of the graft, which allows to remove the cells directly or indirectly (by selecting other
cells to "stay" in the graft").
PRIMARY OBJECTIVES:
I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation
access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted
peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion
(PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation
access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted
peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion
(PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
Inclusion Criteria:
- Patients who received a prior hematopoietic progenitor cell transplantation, including
matched sibling and unrelated donor transplants, mismatched sibling and unrelated
donor transplants and haploidentical transplants from related donors
- Patients with a presence of secondary engraftment failure defined as decrease in donor
chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
- OR a presence of incomplete graft function manifested by presence of persistent or new
cytopenias 60 or more days after transplantation:
- Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements
over the preceding 4 weeks
- Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per
microliter or requirement of growth factor support over the preceding 4 weeks
- Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or
platelet transfusion requirements over the preceding 4 weeks
Exclusion Criteria:
- Patients for whom hematopoietic progenitor cells from the original donor are not
available
- Presence of reversible causes of engraftment failure or incomplete graft function,
including
- Active viral infection
- Medications
- Acute or chronic graft versus host disease (GVHD) that is not controlled to less
or equal than stage II with immunosuppressants
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Paolo F. Caimi
Phone: 216-844-8220
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