Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Recruitment status was Active, not recruiting
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | July 3, 2010 | ||||
Start Date ICMJE | June 2006 | ||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00352365 on ClinicalTrials.gov Archive Site | ||||
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Current Other Outcome Measures ICMJE | |||||
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Descriptive Information | |||||
Brief Title ICMJE | Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia | ||||
Official Title ICMJE | A Phase II Study of Lenalidomide (REVLIMID, NSC-703831) for Previously Untreated Non-M3, Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy | ||||
Brief Summary | RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. |
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Detailed Description | OBJECTIVES:
OUTLINE:
After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | ||||
Intervention ICMJE | Drug: lenalidomide | ||||
Study Arm (s) | |||||
Publications * | Sekeres MA, Gundacker H, Lancet J, Advani A, Petersdorf S, Liesveld J, Mulford D, Norwood T, Willman CL, Appelbaum FR, List AF. A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605. Blood. 2011 Jul 21;118(3):523-8. Epub 2011 May 6. | ||||
* 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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 60 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352365 | ||||
Other Study ID Numbers ICMJE | CDR0000484449, SWOG-S0605 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | ||||
Study Sponsor ICMJE | Southwest Oncology Group | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |