Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sidney Kimmel Comprehensive Cancer Center |
---|---|
Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00867308 |
This is a single center open label phase II study of lenalidomide in IPSS Int-2 and high risk myelodysplastic syndrome (MDS) patients without 5q31.1 deletions and those with 5q31.1 deletions who have failed to respond to standard dose lenalidomide. Patients will receive two cycles of 15 mg daily lenalidomide given on days 1-28 out of a 42 day cycle. Within each of the two cycles of lenalidomide, patients will be given up to three weeks with no drug treatment to recover. Patients who fail to respond after two cycles of treatment may receive two additional cycles if stable. Patients who develop clinical response may continue to receive drug until disease progression.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome |
Drug: Lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Protocol Title: Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD) |
Estimated Enrollment: | 48 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven Gore, MD | (410) 955-8781 |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Steven Gore, MD 410-955-8781 | |
Principal Investigator: Steven Gore, MD |
Responsible Party: | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Steven Gore, MD/Principal Investigator ) |
Study ID Numbers: | J0882, RV- MDS-PI-295 |
Study First Received: | March 19, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00867308 History of Changes |
Health Authority: | United States: Institutional Review Board |
IPSS Int-2 high risk myelodysplastic syndrome MDS) 5q31.1 deletions 5q31.1 deletions |
Leukemia Acute Myelocytic Leukemia Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplastic Syndromes Lenalidomide Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute |
Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions |
Preleukemia Neoplasms Pathologic Processes Syndrome Therapeutic Uses Bone Marrow Diseases |