Status:
COMPLETED
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 trans...
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC) for 7 days. Treatment repeats every 28 days for ...
Eligibility Criteria
Inclusion
- 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
- 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 other organ system that may place the patient at undue risk to undergo treatment
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Females who are pregnant or breastfeeding
- Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment
- Any uncontrolled or significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- Clinical evidence suggestive of central nervous system (CNS) involvement with MDS unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (CSF)
Key Trial Info
Start Date :
August 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01812252
Start Date
August 19 2013
End Date
October 26 2022
Last Update
February 15 2024
Active Locations (4)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
3
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
4
Kaiser Permanente Washington
Seattle, Washington, United States, 98112