Study of Ruxolitinib for Patients With Myelofibrosis (MF)
Status: | Active, not recruiting |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2019 |
Start Date: | September 29, 2016 |
End Date: | September 2020 |
Open-label Roll-Over Study to Assess the Long-term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
The goal of this clinical research study is to collect data about the long term safety and
tolerability of ruxolitinib when given to patients with MF.
tolerability of ruxolitinib when given to patients with MF.
If you agree to take part in this study, you will continue to receive ruxolitinib as
prescribed in Study 2007-0169. In addition, you will have study visits (described below) to
help researchers collect data about any side effects you may be having and what effect, if
any, ruxolitinib is having on you and/or the disease.
Study Drug Administration:
Each study cycle is 28 days. You will take ruxolitinib tablets by mouth with a cup of water
(about 8 ounces) either 1 or 2 times each day. You will continue to receive ruxolitinib at
the same dose and schedule that you were assigned in Study 2007-0169. The study staff will
remind you to which schedule you have been assigned.
You will also be given a study drug diary to write down when you take each dose of
ruxolitinib and if you miss or vomit any doses. You should bring this diary with you to each
clinic visit at MD Anderson.
Study Visits:
At every visit, you will be asked about any side effects you may be having and about any new
drugs (over-the-counter drugs, prescription drugs, and/or herbal/dietary supplements) that
you take or are planning to take.
Every 6 cycles (± 30 days):
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will complete 2 questionnaires about your quality of life. They should take about 10
minutes to complete.
Every 3 cycles, you will be called by the study doctor or a member of the study staff and
asked about any side effects that you may be having and to answer any questions that you
might have about the study. This call should last about 10 minutes.
On Day 1 of Cycle 3 and then every 3 cycles after that (Cycles 6, 9, 12, and so on) (+/- 14
days), blood (about 2-3 tablespoons) will be drawn for routine tests. You may choose to have
these blood draws performed at a local lab or clinic closer to your home. The results of this
testing will then be sent to the study doctor at MD Anderson. The study doctor will discuss
this option with you.
Length of Study:
You may continue taking ruxolitinib for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after follow-up.
End-of-Study Visit:
As soon as possible after your last dose of study drug, if the doctor thinks it is needed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a complete physical exam.
- You will complete the 2 questionnaires about your quality of life.
This is an investigational study. Ruxolitinib is FDA approved and commercially available to
treat MF. It is considered investigational to collect data about the long-term effects of
ruxolitinib. The study doctor can explain how the study drug is designed to work.
Up to 14 participants will be enrolled in this study. All will take part at MD Anderson.
prescribed in Study 2007-0169. In addition, you will have study visits (described below) to
help researchers collect data about any side effects you may be having and what effect, if
any, ruxolitinib is having on you and/or the disease.
Study Drug Administration:
Each study cycle is 28 days. You will take ruxolitinib tablets by mouth with a cup of water
(about 8 ounces) either 1 or 2 times each day. You will continue to receive ruxolitinib at
the same dose and schedule that you were assigned in Study 2007-0169. The study staff will
remind you to which schedule you have been assigned.
You will also be given a study drug diary to write down when you take each dose of
ruxolitinib and if you miss or vomit any doses. You should bring this diary with you to each
clinic visit at MD Anderson.
Study Visits:
At every visit, you will be asked about any side effects you may be having and about any new
drugs (over-the-counter drugs, prescription drugs, and/or herbal/dietary supplements) that
you take or are planning to take.
Every 6 cycles (± 30 days):
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will complete 2 questionnaires about your quality of life. They should take about 10
minutes to complete.
Every 3 cycles, you will be called by the study doctor or a member of the study staff and
asked about any side effects that you may be having and to answer any questions that you
might have about the study. This call should last about 10 minutes.
On Day 1 of Cycle 3 and then every 3 cycles after that (Cycles 6, 9, 12, and so on) (+/- 14
days), blood (about 2-3 tablespoons) will be drawn for routine tests. You may choose to have
these blood draws performed at a local lab or clinic closer to your home. The results of this
testing will then be sent to the study doctor at MD Anderson. The study doctor will discuss
this option with you.
Length of Study:
You may continue taking ruxolitinib for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after follow-up.
End-of-Study Visit:
As soon as possible after your last dose of study drug, if the doctor thinks it is needed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a complete physical exam.
- You will complete the 2 questionnaires about your quality of life.
This is an investigational study. Ruxolitinib is FDA approved and commercially available to
treat MF. It is considered investigational to collect data about the long-term effects of
ruxolitinib. The study doctor can explain how the study drug is designed to work.
Up to 14 participants will be enrolled in this study. All will take part at MD Anderson.
Inclusion Criteria:
1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by
treating physician,
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
enrollment of this study
3. Ability and agreement to attend protocol-specified visits at the study site
4. Able to comprehend and willing to sign the informed consent form
5. Negative pregnancy test in females of childbearing potential. Male patients with
female partners of child-bearing potential and female patients of childbearing
potential are required to use two forms of acceptable contraception, including one
barrier method, during their participation in the study and for 30 days following last
dose. Acceptable forms of contraception include 1 highly effective method such as an
intrauterine device (IUD), hormonal (birth control pills, injections, or implants),
tubal ligation, or partner's vasectomy and at least 1 additional approved barrier
method such as a latex condom, diaphragm, or cervical cap. Female patients of
childbearing potential must not be breast-feeding or planning to breast feed and must
have a negative pregnancy test ≤7 days before first study treatment.
Exclusion Criteria:
1) none
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121

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