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Ruxolitinib and Lenalidomide for Patients With Myelofibrosis

NCT01375140 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-06-08

Study results available
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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.

Conditions

  • Myeloproliferative Diseases

Interventions

DRUG

Ruxolitinib

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

DRUG

Lenalidomide

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

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.

Sponsors & Collaborators

Principal Investigators

  • Srdan Verstovsek, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-22
Primary Completion
2018-09-05
Completion
2018-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375140 on ClinicalTrials.gov