CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Ruxolitinib +2 moredrug
Likely dose
Ruxolitinib 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01375140
NCT01375140Phase 2Completed
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Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis

M.D. Anderson Cancer Center·interventional·Posted Jun 17, 2011·Updated Jun 8, 2025

In Brief

A Phase 2 clinical trial evaluating Ruxolitinib, Lenalidomide, and 1 other intervention for Myeloproliferative Diseases. Completed, enrolled 31 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloproliferative Diseases
CountriesUnited States
CollaboratorsIncyte Corporation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2011
Enrollment StartSep 22, 2011
Primary CompletionSep 5, 2018
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 15.0 years ago

Interventions

Ruxolitinibdrug

15 mg by mouth twice daily (BID), continuously in 28-day cycles.

Lenalidomidedrug

5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.

Prednisonedrug

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.