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| Sponsor: | Nordic MDS Group |
|---|---|
| Information provided by: | Nordic MDS Group |
| ClinicalTrials.gov Identifier: | NCT00761449 |
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 II |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lars Möllgård, MD, PhD | +46 8 58582514 | lars.mollgard@karolinska.se |
| Contact: Eva Hellström-Lindberg, MD, PhD | +46 8 585 825 06 | Eva.Hellstrom-Lindberg@ki.se |
| Denmark | |
| Department of Hematology, Aalborg Hospital | Recruiting |
| Aalborg, Denmark, 9000 | |
| Department of Hematology, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, 8000 | |
| Department of Hematology, Rigshospitalet | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Department of Hematology, Herlev Hospital | Recruiting |
| Herlev, Denmark, 2730 | |
| Department of Hematology, Odense University Hospital | Recruiting |
| Odense, Denmark, 5000 | |
| Department of Hematology, Vejle Hospital | Recruiting |
| Vejle, Denmark, 7100 | |
| Norway | |
| Department of Hematology, Rikshospitalet University Hospital | Recruiting |
| Oslo, Norway, 0027 | |
| Department of Medicine, Ullevål Hospital | Recruiting |
| Oslo, Norway, 0407 | |
| Department of Hematology, Trondheim University Hospital | Recruiting |
| Trondheim, Norway, 7006 | |
| Sweden | |
| Department of Hematology and Coagulation, Sahlgrenska University hospital | Recruiting |
| Gothenburg, Sweden, 413 45 | |
| Department of Hematology, Lund University Hospital | Recruiting |
| Lund, Sweden, 221 85 | |
| Department of Hematology, Malmö University Hospital | Recruiting |
| Malmö, Sweden, 205 02 | |
| Hematology Center, Karolinska University Hospital Solna | Recruiting |
| Stockholm, Sweden, 171 76 | |
| Hematology Center, Karolinska University Hospital Huddinge | Recruiting |
| Stockholm, Sweden, 141 86 | |
| Contact: Lars Möllgård, MD, PhD +46 8 58582514 lars.mollgard@karolinska.se | |
| Principal Investigator: Lars Möllgård, MD, PhD | |
| Department of Medicine, Sundsvall Hospital | Recruiting |
| Sundsvall, Sweden, 851 86 | |
| Department of Medicine, Umeå University Hospital | Recruiting |
| Umeå, Sweden, 901 85 | |
| Department of Hematology, Akademiska University Hospital | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Department of Medicine, Örebro University Hospital | Recruiting |
| Örebro, Sweden, 701 85 | |
| Principal Investigator: | Eva Hellström-Lindberg, MD, PhD | Nordic MDS Group |
More Information
| Responsible Party: | Dr Eva Hellström Lindberg, MD, PhD, 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: | September 29, 2008 |
| Health Authority: | Sweden: Medical Products Agency |
|
MDS AML Lenalidomide monosomy 5 del5q |
|
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 |