Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
King's College Hospital NHS Trust |
---|---|
Information provided by: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00874978 |
The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del (5q31-33) cytogenetic abnormality.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Efficacy and Safety of Lenalidomide (Revlimid®) Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome Associated With Del (5q) Cytogenetic Abnormality |
Estimated Enrollment: | 36 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
lenalidomide: Experimental |
Drug: lenalidomide
Oral lenalidomide 10mg (two 5mg capsules) daily on days 1-21 every 28 days for up to 6 cycles.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory test results within these ranges:
Exclusion Criteria:
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath | +44 (0) 20 3299 9000 ext 3238 | ghulam.mufti@kcl.ac.uk |
United Kingdom | |
King's College Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, SE5 9RS | |
Contact: Ghulam J Mufti, MB, DM, FRCP, FRCPath +44 (0) 20 3299 9000 ext 3238 ghulam.mufti@kcl.ac.uk |
Principal Investigator: | Ghulam J Mufti, MB, DM, FRCP, FRCPath | King's College London |
Responsible Party: | King's College London ( Professor Ghulam Mufti ) |
Study ID Numbers: | 04CC06, REC - 04/Q0703/148, EudraCT - 2004-005101-29 |
Study First Received: | March 16, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00874978 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Lenalidomide myelodysplastic syndromes |
Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes |
Lenalidomide Chromosome Aberrations Bone Marrow Diseases Congenital Abnormalities |
Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions |
Preleukemia Neoplasms Pathologic Processes Syndrome Therapeutic Uses Chromosome Aberrations Bone Marrow Diseases |