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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nordic MDS Group
ClinicalTrials.gov Identifier:
NCT00761449
First received: September 26, 2008
Last updated: April 26, 2012
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
MDS
AML
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nordic MDS Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minor and complete cytogenetic (FISH) response after 8 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Red blood cell transfusion independence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Erythroid response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Bone marrow response (morphology) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Modification of gene expression profiling during treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761449

Locations
Denmark
Department of Hematology, Aalborg Hospital
Aalborg, Denmark, 9000
Department of Hematology, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Hematology, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Hematology, Herlev Hospital
Herlev, Denmark, 2730
Department of Hematology, Odense University Hospital
Odense, Denmark, 5000
Department of Hematology, Vejle Hospital
Vejle, Denmark, 7100
Norway
Department of Hematology, Rikshospitalet University Hospital
Oslo, Norway, 0027
Department of Medicine, Ullevål Hospital
Oslo, Norway, 0407
Department of Hematology, Trondheim University Hospital
Trondheim, Norway, 7006
Sweden
Department of Hematology and Coagulation, Sahlgrenska University hospital
Gothenburg, Sweden, 413 45
Department of Hematology, Lund University Hospital
Lund, Sweden, 221 85
Department of Hematology, Malmö University Hospital
Malmö, Sweden, 205 02
Hematology Center, Karolinska University Hospital Solna
Stockholm, Sweden, 171 76
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
Department of Medicine, Sundsvall Hospital
Sundsvall, Sweden, 851 86
Department of Medicine, Umeå University Hospital
Umeå, Sweden, 901 85
Department of Hematology, Akademiska University Hospital
Uppsala, Sweden, 751 85
Department of Medicine, Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Nordic MDS Group
Investigators
Principal Investigator: Eva Hellström-Lindberg, MD, PhD Nordic MDS Group
  More Information

Additional Information:
No publications provided by Nordic MDS Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nordic MDS Group
ClinicalTrials.gov Identifier: NCT00761449     History of Changes
Other Study ID Numbers: NMDSG07A, EudraCT no: 2007-000450-31
Study First Received: September 26, 2008
Last Updated: April 26, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Nordic MDS Group:
MDS
AML
Lenalidomide
monosomy 5
del5q

Additional relevant MeSH terms:
Monosomy
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014