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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761449
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
Nordic MDS Group

Brief Summary:
The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.

Condition or disease Intervention/treatment Phase
MDS AML Drug: lenalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
1. lenalidomide
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Minor and complete cytogenetic (FISH) response after 8 and 16 weeks [ Time Frame: 16 weeks ]
  2. Red blood cell transfusion independence [ Time Frame: 16 weeks ]
  3. Erythroid response [ Time Frame: 16 weeks ]
  4. Bone marrow response (morphology) [ Time Frame: 16 weeks ]
  5. Modification of gene expression profiling during treatment [ Time Frame: 16 weeks ]
  6. Safety [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761449

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Sponsors and Collaborators
Nordic MDS Group
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Principal Investigator: Eva Hellström-Lindberg, MD, PhD Nordic MDS Group
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nordic MDS Group Identifier: NCT00761449    
Other Study ID Numbers: NMDSG07A
EudraCT no: 2007-000450-31
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: January 2010
Keywords provided by Nordic MDS Group:
monosomy 5
Additional relevant MeSH terms:
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Chromosome Aberrations
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents