Ruxolitinib and Lenalidomide for Patients With Myelofibrosis
The goal of this clinical research study is to learn if the combination of ruxolitinib and lenalidomide can help to control MF. The safety of this study drug combination will also be studied.
Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF cells from sending signals that may lead to the growth of cancer cells.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis|
- Objective Response Rate [ Time Frame: 3 cycles (28 days each) up to 3 months ] [ Designated as safety issue: Yes ]Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Ruxolitinib + Lenalidomide
Ruxolitinib 15 mg orally twice daily continuously + Lenalidomide orally 5 mg/day on days 1-21, followed by 7 days of no therapy (28-day cycle). Prednisone will be added for patients who have not responded after 3 cycles of therapy. Prednisone 30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.
15 mg by mouth twice daily (BID), continuously in 28-day cycles.
Other Name: INCB018424Drug: Lenalidomide
5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.
Other Names:Drug: Prednisone
Prednisone will be added for patients who have not responded after 3 cycles of therapy.
30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01375140
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek, MD||M.D. Anderson Cancer Center|