Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis
Study Drug Administration:
If you are found eligible to take part in this study, you will begin taking ruxolitinib by
mouth 2 times every day during each 28-day cycle. You should take ruxolitinib one time in
the morning and one time in the evening (about 12 hours apart). Ruxolitinib should be taken
with a meal and a glass of water. If you miss a dose of ruxolitinib, you should not make up
the dose or take any more before the next scheduled dose.
You will also take lenalidomide by mouth one time in the morning on Days 1-21 of each cycle.
Lenalidomide capsules should be swallowed whole, and should not be broken, chewed, or
opened. If a dose of lenalidomide is missed, it should be taken as soon as possible on the
same day. If it is missed for the entire day, it should not be made up.
If your study doctor thinks it is needed or if you have side effects, your dose of
ruxolitinib and/or lenalidomide may be stopped, lowered, or delayed for up to 8 weeks during
the study.
During the study, you will need to return all unused study drug to the study staff at each
clinic visit.
Additional Drugs:
If your disease has not responded to the study drugs after 3 cycles and the study doctor
thinks it is in your best interest, you may begin taking prednisone along with the study
drugs. Prednisone is a corticosteroid that is similar to a natural hormone made by your
body. Prednisone is often given in combination with other chemotherapy drugs. You will take
prednisone every morning during Cycles 4 and 5, then every other day during Cycle 6. After
Cycle 6, you will no longer take prednisone. If you forget to take a does of prednisone and
more than 8 hours have passed, wait until the next day to take prednisone again (or 2 days
later if you are taking it every other day during Cycle 6).
If your doctor thinks it is needed, you may take aspirin during this study to help prevent
blood clots from forming. If you are allergic to aspirin or cannot take aspirin, your
doctor may recommend you take another type of drug to help prevent blood clots from forming.
Study Drug Diary:
You will be given a study drug diary before you begin taking the study drugs to write down
what time you take each dose of the study drugs. You will need to bring the diary with you
to each study visit so it can be reviewed.
You should bring the study drug (including empty bottles) with you to all of the study
visits. You will be asked not to take your morning dose of study drug before your visits on
Day 15 Cycle 1 and Day 1 on Cycle 2.
Study Visits:
On Day 1 of Cycles 1 and 2:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your kidney and
liver function. This routine blood draw will include a pregnancy test if you are able
to become pregnant.
- You will complete 2 questionnaires about your quality of life. The questionnaires
should take about 10 minutes to complete. One of the questionnaires may be filled out
on a computer. The study staff will help you use the computer.
On Days 8 and 22 of Cycles 1 and 2:
-Blood (about 3 teaspoons) will be drawn for routine tests. This routine blood draw will
include a pregnancy test if you are able to become pregnant.
On Day 15 of Cycles 1 and 2:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any side effects you may be having.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your kidney and
liver function. This routine blood draw will include a pregnancy test if you are able
to become pregnant.
On Day 1 of Cycle 3 and every 3 Cycles after that:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a review of any blood transfusions you may have had in the last 3 months.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your kidney and
liver function. This routine blood draw will include a pregnancy test if you are able
to become pregnant.
- You will complete 2 questionnaires about your quality of life. The questionnaires
should take about 10 minutes to complete.
After the Cycle 3 visit, you may begin having bone marrow biopsies and/or aspirates to check
the status of the disease every 3 cycles for 1 year.
Interactive Voice Response (IVR) System:
During the first 3 cycles, you will use the Interactive Voice Response (IVR) system once a
month to tell the study staff about any side effects you may be having. The IVR system is an
automated calling system that will allow you to press buttons on your phone to answer
questions about any side effects you may be having. The study staff will give you
instructions on how to use the IVR. If you are not able to use the IVR system, a member of
the study staff will contact you instead.
After Cycle 3, a member of the study staff will call you at your home once a month to ask
you about any side effects you may be having and to review the results of your blood tests.
Length of Study:
You may receive the study drug combination for up to 2 years. You will no longer be able to
take the study drugs if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
You will be considered off study after your follow-up visit.
End-of-Study Visit:
You will have an end-of-study visit the day you are taken off study. The following tests and
procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a review of any blood transfusions you may have had in the last 3 months.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your kidney and
liver function. This routine blood draw will include a pregnancy test if you are able
to become pregnant.
- You will complete 2 questionnaires about your quality of life. The questionnaires
should take about 10 minutes to complete.
- You will have a bone marrow biopsy and/or aspirate to check the status of the disease.
Follow-up:
A member of the study staff will call you 30 days and 60 days after you have stopped taking
the study drugs to ask how you are feeling and if you have had any side effects since your
last visit.
This is an investigational study. Lenalidomide is not FDA-approved or commercially
available for use in patients with MF. Ruxolitinib is FDA approved and commercially
available for the treatment of intermediate or high-risk myelofibrosis, including primary
myelofibrosis, post-polycythemia vera (post-PV) myelofibrosis and post-essential
thrombocythemia (post-ET) myelofibrosis. Lenalidomide is FDA-approved for the treatment of
some forms of myelodysplastic syndrome (MDS) and multiple myeloma (MM). Its use in patients
with MF is investigational.
Up to 49 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
3 cycles (28 days each) up to 3 months
Yes
Srdan Verstovsek, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0269
NCT01375140
September 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |