A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives (NCT01532635) | Clinical Trial Compass
TerminatedPhase 2
A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives
Stopped: Slow accrual
United States4 participantsStarted 2012-03
Plain-language summary
This phase II clinical trial studies how well two donors stem cell transplant work in treating patients with high-risk hematologic malignancies. After receiving radiation to help further treat the disease, patients receive a dose of donors' T cells. T cells can fight infection and react against cancer cells. Two days after donors' T cells are given, patients receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not destroyed by CY and they remain in the patient to help fight infection. A few days after the CY is given, patients receive donors' stem cells to help their blood counts recover. Using two donors' stem cell transplant instead of one donor may be more effective in treating patients with high-risk disease and may prevent the disease from coming back.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Any patient with a hematologic malignancy with residual disease (morphological, cytogenetic, molecular, or radiographic) after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely or who is in 3rd or greater CR. Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (i.e. \<5% blasts in acute leukemia) but who does not have full count recovery will be eligible for treatment on this high risk trial.
✓. Patients must have two related donors that meet an acceptable scenario as described above.
✓. Patients must adequate organ function:
✓. Karnofsky Performance Status of \> 80 % on the modified KPS tool (see Appendix A).
✓. Patients must be willing to use contraception if they have childbearing potential.
✓. Able to give informed consent
Exclusion criteria
✕. Modified KPS of \< 80%
✕. \>= 5 Comorbidity Points on the HCT-CI Index (See Appendix B)
What they're measuring
1
One Year Relapse-Free Survival
Timeframe: 1 year
Trial details
NCT IDNCT01532635
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University