Ruxolitinib and Lenalidomide for Patients With Myelofibrosis

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01375140
Phase
PHASE2
Status
Completed

Conditions

  • Myeloproliferative Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    15 mg by mouth twice daily (BID), continuously in 28-day cycles.
  • Lenalidomide — DRUG
    5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.
  • Prednisone — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 22, 2011
Status verified
May 2025
Primary completion
Sep 5, 2018
Completion
Sep 5, 2018

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Participants With Objective Response [ Time Frame: 3 cycles (28 days each) up to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies