Treosulfan vs. Clofarabine-Based Conditioning

A Phase II Randomized Study to Assess Outcomes With Treosulfan-Based Versus Clofarabine-Based Conditioning in Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)

What's the purpose of the trial?

This phase II trials studies the effect of treosulfan-based versus clofarabine-based conditioning regimens before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes, or acute myeloid leukemia. Chemotherapy drugs, such as treosulfan, fludarabine, and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation before a donor hematopoietic stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. This study may help doctors determine whether treosulfan-based or clofarabine-based conditioning regimen works better before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes, or acute myeloid leukemia.

Trial status

Accepting patients

Phase
Phase 2
Enrollment
80
Last Updated
1 month ago
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Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

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.
  • Clofarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Total Body Irradiation is radiation therapy that is given to your entire body.
  • Treosulfan is a chemotherapy medication given to people before stem cell transplantation.

Arms / Cohorts

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Accepting patients

Arm A: Treosulfan + Fludarabine

Accepting patients

Arm B: Clofarabine

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