Status:
TERMINATED
Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Celgene Corporation
Conditions:
Myelodysplastic Syndromes
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this phase I study will...
Detailed Description
Cytogenetics are the main predictors of outcome in patients with AML. In fact, a monosomy 5 or del (5q) as single aberration are poor prognostic markers. Overall, the complete response rate for conven...
Eligibility Criteria
Inclusion
- Understand and voluntarily sign an informed consent form.
- Age \>=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Relapsed or refractory AML (\>30% blasts, FAB classification)with karyotype abnormalities involving monosomy 5 or del(5q) or MDS and t-MDS INT-2 or HIGH according to IPSS classification with karyotype abnormalities involving monosomy 5 or del(5q) either previously treated or untreated
- Not eligible for an immediate allogeneic HSCT (due to donor unavailability)
- All previous MDS or AML specific therapy with exception of corticosteroids not exceeding doses of 10mg/day prednisone must have been discontinued at least 1 week prior to study enrollment.
- Non-hematological toxicity (except alopecia) resulting from previous treatment must be resolved to WHO CTC Grade ≤ 2.
- ECOG performance status of \< 3 at study entry.
- Laboratory test results within these ranges:Serum creatinine \<= 2.0 mg/dL, Total bilirubin \<= 3 x ULN, AST (SGOT) and ALT (SGPT) \<= 3 x ULN
- Females of childbearing potential must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while on study).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Known hypersensitivity to thalidomide, lenalidomide, 5-azacitidine or mannitol.
- Myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Uncontrolled lung disease.
- Known positive for HIV or acute infectious hepatitis, type A, B or C.
- Participation in another clinical study in the 4 weeks prior to enrollment or during this study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00923234
Start Date
June 1 2009
End Date
July 1 2012
Last Update
December 18 2013
Active Locations (4)
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1
Medizinische Klinik und Poliklinik I, Uniklinik
Dresden, Germany
2
Universitätsklinikum Düsseldorf, Klinik für Hämatologie/Onkologie/klinische Immunologie
Düsseldorf, Germany, 40225
3
Klinikum der J.W. Goethe-Universität, Medizinische Klink II
Frankfurt, Germany, 60590
4
Technische Universität München, Klinikum Rechts der Isar
München, Germany, 81675