Trials / Completed
CompletedNCT01812252
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Arm B: Patients receive induction-like chemotherapy per standard of care or per experimental protocol. This study does not require a specific chemotherapy regimen for Arm B. After completion of study treatment, patients are followed up for 18 months.
Conditions
- Chronic Myelomonocytic Leukemia
- de Novo Myelodysplastic Syndrome
- Myelodysplastic Syndrome
- Secondary Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine (AZC) | Given IV or SC |
| DRUG | Decitabine | Given IV or SC |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
Timeline
- Start date
- 2013-08-19
- Primary completion
- 2022-10-26
- Completion
- 2022-10-26
- First posted
- 2013-03-18
- Last updated
- 2024-02-15
- Results posted
- 2024-02-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01812252. Inclusion in this directory is not an endorsement.