Status:
COMPLETED
5-azacytidine Treatment Versus 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
55-70 years
Phase:
PHASE2
Brief 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 ass...
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 ass...
Eligibility Criteria
Inclusion
- Patients with proven de novo or therapy-related MDS / CMML (WBC \<13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts ≤ 30 % (= RAEB-t according to FAB)
- Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)
- Male or Female; Age 55 - 70 years
- Understand and voluntarily sign an informed consent form
- ECOG performance status of ≤ 2 at study entry
- Adequate renal and liver function: creatinine and bilirubin \< 3 x the upper limit of normal
- Sufficient cardiac function (ejection fraction \> 30 %)
Exclusion
- Blasts \> 30 % in bone marrow at time of diagnosis
- Central nervous involvement
- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- Total bilirubin, SGPT or SGOT ≥ 3 times upper the normal level
- Left ventricular ejection fraction \< 30 %
- Creatinine clearance \< 30 ml/min
- DLCO \< 35 % and/or receiving supplementary continuous oxygen
- Pregnant or breastfeeding female subject
- Patients with a life-expectancy of less than six months because of another debilitating disease
- Serious psychiatric or psychological disorders
- Uncontrolled invasive fungal infection at time of registration
- Known positive for HIV or acute infectious hepatitis, type A, B or C
- Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01404741
Start Date
July 1 2011
End Date
July 1 2021
Last Update
October 27 2023
Active Locations (17)
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1
Charité Campus Benjamin Franklin
Berlin, Germany
2
Uniklinikum Bonn
Bonn, Germany
3
Universität zu Köln
Cologne, Germany
4
Universitätsklinikum Dresden
Dresden, Germany, 01307