NCT01404741

5-azacytidine Treatment Versus 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Myelodysplastic Syndrome (MDS)

Comparison Between 5-azacytidine Treatment and 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS), but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. In the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with MDS (55-70 years).

Detailed description

5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS), but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. Dose-reduced conditioning prior transplantation allows also treatment of elderly patients with MDS. In the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with MDS (55-70 years).

Conditions

• Myelodysplastic Syndrome
• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
PROCEDURE	allogeneic stem cell transplantation	donor available, after 4 cycles 5-azacytidine allogeneic stem cell transplantation after reduced conditioning
PROCEDURE	5-azacytidine until progress	if no donor available 5-azacytidine until progress or toxicities

Timeline

• Start date: 2011-07-01
• Primary completion: 2020-05-01
• Completion: 2021-07-01
• First posted: 2011-07-28
• Last updated: 2023-10-27

Locations

17 sites across 1 country: Germany