Lenalidomide and Prednisone in Treating Patients With Myelofibrosis
Recruitment status was Active, not recruiting
RATIONALE: Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis.
Chronic Myeloproliferative Disorders
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia|
- Overall response monthly [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
- Determine the rate of complete or partial remission in patients with myelofibrosis with myeloid metaplasia treated with lenalidomide and prednisone.
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine the effect of this regimen on bone marrow fibrosis, angiogenesis, and cytogenetics in these patients.
OUTLINE: This is a multicenter study.
For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28 and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Patients with stable or responding disease after course 3 receive oral lenalidomide alone once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years from study entry.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 11 months.
Show 90 Study Locations
|Study Chair:||Ayalew Tefferi, MD||Mayo Clinic|
|Investigator:||Larry D. Cripe, MD||Indiana University Melvin and Bren Simon Cancer Center|