A Study Using Chemotherapy to Treat Patients with Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 15-003502
NCT ID: NCT01812252
Sponsor Protocol Number: 2661.00
About this study
The purpose of this study is to see the effect of a chemotherapy treatment for 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Diagnosis of new 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
- A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health Organization classification system
- Previous treatment for MDS or 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)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Nandita Khera, M.D., M.P.H.
Closed for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available