Graft Versus Host Disease-Reduction Strategies

A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)

What's the purpose of the trial?

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
120
Last Updated
3 months ago
Am I Eligible

Participating Centers

There are 3 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Allogeneic Stem Cell Transplant is a type of stem cell transplant that utilizes a donor's pre-collected stem cells to rescue the bone marrow from the toxic effects of very high dose chemotherapy.
  • Busulfan is a chemotherapy cancer medication that interferes with the growth and spread of cancer cells in the body, and may be used in the treatment of many different cancers.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Cyclosporine is a drug that suppresses the immune system. It may be used in patients who have had organ transplants, autoimmune disorders, or graft vs host disease.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Sirolimus is an immunosuppressive medication used in several indications, including to help prevent rejection in patients who have had a transplant.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Total Body Irradiation Based

Accepting patients

Busulfan Based

Accepting patients

TBI, PTCy, tacrolimus)

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