NCT00227591

Lenalidomide and Prednisone in Treating Patients With Myelofibrosis

A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. 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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the rate of complete or partial remission from treatment with a combination of lenalidomide and prednisone in patients with myelofibrosis with myeloid metaplasia. SECONDARY OBJECTIVES: I. To examine drug toxicity. II. To examine duration of response. III. To examine the effect of treatment on bone marrow fibrosis, angiogenesis, and cytogenetics. OUTLINE: 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.

Conditions

• Essential Thrombocythemia
• Polycythemia Vera
• Primary Myelofibrosis

Interventions

Type	Name	Description
DRUG	lenalidomide	Given orally (PO)
DRUG	prednisone	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-09-28
• Last updated: 2014-05-21
• Results posted: 2013-09-26

Locations

1 site across 1 country: United States