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Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5

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ClinicalTrials.gov Identifier: NCT00761449
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Nordic MDS Group

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 29, 2008
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe, see section 8.3) after 16 weeks of lenalidomide treatment [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT00761449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
  • Minor and complete cytogenetic (FISH) response after 8 and 16 weeks [ Time Frame: 16 weeks ]
  • Red blood cell transfusion independence [ Time Frame: 16 weeks ]
  • Erythroid response [ Time Frame: 16 weeks ]
  • Bone marrow response (morphology) [ Time Frame: 16 weeks ]
  • Modification of gene expression profiling during treatment [ Time Frame: 16 weeks ]
  • Safety [ Time Frame: 16 weeks ]
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 Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
Official Title  ICMJE A Multicentre Phase II Study of the Efficacy and Safety of Lenalidomide in High-risk Myeloid Disease (High-risk MDS and AML) With a Karyotype Including Del(5q) or Monosomy 5
Brief Summary The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.
Detailed Description Previous studies have shown that the immunomodulatory drug lenalidomide is effective in the treatment of low risk MDS with del(5q). Treatment of this subgroup of MDS patients resulted in 67% major erythroid responses and 45% complete cytogenetic responses. We therefore intend to test the efficacy of lenalidomide in a group of high-risk patients who are ineligible for conventional chemotherapy and who have a dismal prognosis. The patients must have a karyotype including del(5q) but patients with a karyotype including monosomy 5 are also eligible. We hypothesize that hight risk MDS or AML patients with other chromosomal aberrations than del(5q) can be affected by the lenalidomide effect.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • MDS
  • AML
Intervention  ICMJE Drug: lenalidomide
Initial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks.
Other Name: Revlimid
Study Arms  ICMJE Experimental: 1
1. lenalidomide
Intervention: Drug: lenalidomide
Publications * Möllgård L, Saft L, Treppendahl MB, Dybedal I, Nørgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jädersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Grønbæk K, Hellström-Lindberg E. Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities. Haematologica. 2011 Jul;96(7):963-71. doi: 10.3324/haematol.2010.039669. Erratum in: Haematologica. 2011 Aug;96(8):1240. Lindberg, Eva Hellström [corrected to Hellström-Lindberg, Eva].

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
50
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be >18 years of age at the time of signing the informed consent form
  • MDS at IPSS Int-2 or High with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
  • Acute myeloid leukemia with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
  • Patients could be included if:
  • At diagnosis and not considered eligible for induction chemotherapy
  • Refractory to induction therapy
  • Relapse after induction chemotherapy leading to CR and considered not eligible for reinduction
  • Relapse after allogeneic stem cell transplantation and not considered suitable for reinduction chemotherapy or other conventional relapse therapy.
  • Subject has signed the informed consent document.
  • Women of childbearing potential, WCBP, must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of the study medication, while on study medication and 4 weeks after the last dose of study medication. WCBP must have two negative serum or urine pregnancy tests prior to starting study drug. WCBP must agree to have pregnancy tests weekly for the first 4 weeks and then every 4 weeks while on study medication and 4 weeks after the last dose of study medication.
  • Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Prior therapy with lenalidomide
  • Patients who are eligible for curative treatment
  • Expected survival less than two months.
  • Acute promyelocytic leukemia (APL)
  • Absolute peripheral blast count >30,000/mm3
  • Central nervous system leukemia
  • Serum biochemical values as follows
  • Serum creatinine >2.0 mg/dL (177 micromol/L)
  • Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)
  • Serum total bilirubin >1.5 mg/dL (26 micromol/L)
  • Prior allergic reaction to thalidomide
  • Uncontrolled systemic infection
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 Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00761449
Other Study ID Numbers  ICMJE NMDSG07A
EudraCT no: 2007-000450-31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nordic MDS Group
Study Sponsor  ICMJE Nordic MDS Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eva Hellström-Lindberg, MD, PhD Nordic MDS Group
PRS Account Nordic MDS Group
Verification Date January 2010

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