Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
This study has been completed.
Sponsor:
Nordic MDS Group
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
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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:
Genetics Home Reference related topics:
tetrasomy 18p
Drug Information available for:
Lenalidomide
U.S. FDA Resources
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
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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013