Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant — ICT-HCT  

Myelodysplastic Syndrome Clinical Trial

Official title: Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• de Novo Myelodysplastic Syndrome
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Secondary Myelodysplastic Syndrome
• Syndrome

• NCT number: NCT01812252
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: August 19, 2013
• Completion date: October 26, 2022