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

NCT01404741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2023-10-27

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Nicolaus Kroeger, Prof. · University Medical Centre Hamburg-Eppendorf, Stem-Cell-Transplantation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2020-05-31
Completion
2021-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404741 on ClinicalTrials.gov