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Trial record 11 of 16 for:    LENALIDOMIDE AND Leukemia AND Azacitidine

Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes (AZALE)

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ClinicalTrials.gov Identifier: NCT00923234
Recruitment Status : Terminated (The primary objective has already been answered with the number of recruited patients.)
First Posted : June 18, 2009
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE June 17, 2009
First Posted Date  ICMJE June 18, 2009
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Maximum tolerated dose (MTD) of Revlimid® (lenalidomide)in combination with Vidaza®(5-azacitidine) [ Time Frame: during first cycle of therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00923234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
  • Clinical and cytogenetic response [ Time Frame: during therapy ]
  • Safety (type, frequency, severity, and relationship of adverse events to study treatment) [ Time Frame: during therapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes
Official Title  ICMJE A Phase I Study of a Combination of 5-azacitidine Followed by Lenalidomide in High-risk MDS or Relapsed/Refractory AML Patients With Cytogenetic Abnormalities Including -5 or Del(5q)
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 investigate the maximum tolerated dose (MTD) of lenalidomide in combination with a fixed dose of 5-aza in this patient population.
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 conventionally treated patients with newly-diagnosed AML with chromosome 5 abnormalities is about 31% to 37 % and all patients rapidly relapse if not rescued by allogeneic HSCT. The situation is almost similar in patients with high-risk MDS.Vidaza® has been shown in clinical trials to achieve remission rates in about 29% (CR+PR) of the patients while a total of 49% achieve improvement of blood counts.Revlimid® is also able to achieve complete remissions in advanced MDS and even overt leukemia with or without chromosome 5 abnormalities. Nevertheless, response rates are lower compared to low-risk MDS (IPSS Low/INT-1). Therefore, Revlimid® seems to be too weak as a single agent, but a promising compound for a combination therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelodysplastic Syndromes
  • Acute Myelogenous Leukemia
Intervention  ICMJE
  • Drug: Azacitidine
    75 mg/m² SC days 1-5 every 28 days for a maximum of 8 cycles
    Other Name: Vidaza
  • Drug: Lenalidomide
    10 - 25 mg PO days 6-19 every 28 days for a maximum of 8 cycles
    Other Name: Revlimid
Study Arms  ICMJE Experimental: Azacitidine and Lenalidomide
Azacitidine 75 mg/m² SC days 1-5 every 28 days for a maximum of 8 cycles and Lenalidomide 10 - 25 mg PO days 6-19 every 28 days for a maximum of 8 cycles
Interventions:
  • Drug: Azacitidine
  • Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2009)
30
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00923234
Other Study ID Numbers  ICMJE TUD-AZALE1-037
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Uwe Platzbecker, MD Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
PRS Account Technische Universität Dresden
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP