Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant (NCT01812252) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
United States50 participantsStarted 2013-08-19
Plain-language summary
This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of de novo or secondary myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia, as defined by the 2008 World Health Organization classification system
* Patients must have measurable disease requiring cytoreduction, defined as a bone marrow myeloblast count \>= 5% and \< 20% on morphologic examination or by flow cytometry in cases in which adequate morphologic examination is not possible
* Patients must be considered to have an acceptable risk of early mortality with intensive chemotherapy as determined by the attending physician at the time of the initial visit; since the specific therapy within each arm will be determined after randomization, there is no threshold of organ dysfunction or performance status for inclusion
* Considered a potential transplant candidate; the attending/treating physician will determine transplant candidacy at the time of consent
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Exclusion Criteria:
* A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health Organization classification system
* Previous treatment for MDS or acute myeloblastic leukemia (AML) with intensive chemotherapy regimen (induction chemotherapy) or hypomethylating agent
* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or othe…
What they're measuring
1
Failure-free Survival (Failure Defined as Death or Relapse)