Ruxolitinib and Lenalidomide for Patients With Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT01375140|
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : July 31, 2019
Last Update Posted : July 31, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Diseases||Drug: Ruxolitinib Drug: Lenalidomide Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis|
|Actual Study Start Date :||September 22, 2011|
|Actual Primary Completion Date :||September 5, 2018|
|Actual Study Completion Date :||September 5, 2018|
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: INCB018424
5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.
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.
- Participants With Objective Response [ Time Frame: 3 cycles (28 days each) up to 3 months ]To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts <5%, hemoglobin >/= 10, absolute neutrophil count (ANC) >/= 1000, platelets >/= 100, <2% immature myeloid cell, spleen and liver not palpable. Partial Response (PR): CR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin >/= 8.5 but < 10, <2% immature myeloid cells. Clinical improvement (CI): hemoglobin increase of 2g/dl, transfusion independence or reduction splenomegaly and/or hepatomegaly >/= 50%, >/=50% reduction in MPN-SAF TSS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|