Trial of High Dose Lenalidomide in Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Trilineage Dysplasia (AML-TLD)
Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | January 27, 2012 | ||||
Start Date ICMJE | March 2009 | ||||
Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary endpoint is hematologic response rate (defined by IWG 2006 response criteria) following administration of 2 - 4 cycles of lenalidomide 15 mg. Response will be assessed following administration of two 42 day treatment cycles. [ Time Frame: End of cycle (42 day treatment) ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00867308 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To determine and describe toxicity of higher doses of lenalidomide in patients with MDS and AML-TLD who do not harbor the 5q31.1.deletion and those who have such a deletion but have failed to respond to standard dose lenalidomide [ Time Frame: End of cycle (42 day treatment) ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Trial of High Dose Lenalidomide in Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Trilineage Dysplasia (AML-TLD) | ||||
Official Title ICMJE | Protocol Title: Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD) | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndrome | ||||
Intervention ICMJE | Drug: Lenalidomide
Lenalidomide 15 mg PO daily on days 1 - 28 out of a 42 day cycle for 4 cycles. |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 48 | ||||
Completion Date | |||||
Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867308 | ||||
Other Study ID Numbers ICMJE | J0882, RV- MDS-PI-295 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE | |||||
Information Provided By | Sidney Kimmel Comprehensive Cancer Center | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |