Polycythemia VeraPhase 2NCT00946270
Pomalidomide for Myelofibrosis Patients
A Phase 2 study testing CC-4047 and Prednisone in people with Polycythemia Vera and Thrombocythemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and prednisone can help to control MMM. The safety of this therapy will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera, Thrombocythemia
- What is being tested?
- CC-4047 and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2009to 22 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be >/= 18 years of age at the time of voluntarily signing an Institutional Review Board/Independent Ethics Committee (IRB/IEC) - approved informed consent form.
- Must be diagnosed with myelofibrosis requiring therapy including myelofibrosis with myeloid metaplasia (MMM), de novo presentation (i.e. agnogenic myeloid metaplasia [AMMM], and developing after an antecedent history of Polycythemia vera (i.e., post-polycythemic myeloid metaplasia [PPMM]), or essential Polycythemia (i.e., post thrombocythemic myeloid metaplasia [PTMM]).
- Screening total hemoglobin level < 10 g/dL or transfusion-dependent anemia defined as per International Working Group (IWG) criteria (transfusion dependency defined by a history of a least 2 units of red blood cell transfusions in the last 28 days for hemoglobin < 8.5 g/dL that was not associated with overt bleeding)
- Must have adequate organ function as demonstrated by the following </= 14 days prior to starting study drug: ·Alanine transaminase (ALT) (SGOT) and Aspartate aminotransferase (AST) (SGPT) </= 3 x upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH)] ·Total bilirubin < 3 x ULN or Direct Bilirubin < 2 x ULN ·Serum creatinine </= 2.5 mg/dL ·Absolute neutrophil count >/= 1,000/µL (>/=1.0 x 10^9/L) ·Platelet count >/= 50,000/µL (>/=50 x 10^9/L)
- Subjects must be willing to receive transfusion of blood products
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at screening.
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- Must be willing to adhere to the study visit schedule and other protocol requirements.
- No active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma (in situ) of the cervix or breast
- All study participants must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program.
- Females of reproductive potential (FCBP†) must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Who cannot join
- Known positive status for HIV, hepatitis B carrier, or active hepatitis C infection.
- The use of any growth factors, cytotoxic chemotherapeutic agents (e.g. hydroxyurea), corticosteroids, or experimental drug or therapy within 14 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.
- Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or lactating females
- Prior use of CC-4047
- Currently enrolled on another clinical trial or receiving investigational agent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II, Prospective, Open Label Study (PO-MMM-PI-0011) to Determine the Safety and Efficacy of Pomalidomide (CC-4047) in Subjects With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, or Post-ET MF)
The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and prednisone can help to control MMM. The safety of this therapy will also be studied.
Read the detailed description
The Study Drug:
CC-4047 is a drug that may also affect the growth of blood vessels that support tumor growth. If these blood vessels stop growing, it may stop cancer cell growth.
Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with other chemotherapy to treat cancer.
Study Drug Administration:
On Days 1- 28 of every 28-day study "cycle," you will take CC-4047 capsule(s) by mouth. You should take the capsule(s), about the same time every day. The capsule(s) should not be opened, broken, or chewed. CC-4047 should be taken without food, at least 2 hours before or 2 hours after a meal. If a dose of CC-4047 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, rather it should be taken at the next scheduled time point.
In order to take part in this study, you must register into and follow the requirements of the POMALYST REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of exposing unborn children to the study drug, and the risks of blood clots and reduced blood counts. You will be required to receive counseling, follow the pregnancy testing and birth control requirements of the program that are appropriate for you, and take surveys regarding how well you are following with the POMALYST REMS™ program.
You will receive prednisone by mouth during the first 3 cycles of therapy. You will take it 1 time a day during Cycle 1. During Cycle 2, you will take a smaller dose 1 time a day. During Cycle 3, you will take the same dose as in Cycle 2, but only 1 time every other day.
On Days 1-28, you will also take low-dose aspirin. This should be taken at the same time as CC-4047. Aspirin is take to help prevent blood clots, which may occur from taking CC-4047. If you are unable to take aspirin, your study doctor will have you take another drug.
You will be given a study "diary". In this diary, you will record when you take each dose of the study drug. You will return any unused study drug and empty bottles at each visit.
Study Visits:
On Day 1 of Cycles 1 and 2, the following tests and procedures will be performed:
- You will have a physical exam, including measurements of your vital signs (blood pressure, temperature, and heart rate) and weight.
- You will be asked about any drugs you are taking and about recent blood transfusions you may have had.
- You will have a performance status evaluation.
- Blood (about 1 tablespoon) will be drawn for routine tests.
On Days 1, 8, 15, and 22 of Cycles 1 and 2, blood (about 4 teaspoons) will be drawn for routine tests.
On Day 28 of each cycle, the following tests and procedures will be performed:
- You will be asked about any drugs you are taking and about recent blood transfusions you may have had.
- You will be asked about any birth control methods you are using.
- Blood (about 4 tablespoons) will be drawn for routine tests.
- You will be asked about any new side effects or medical conditions you may have experienced.
- You will complete a questionnaire about your quality-of-life as well as an assessment of possible pain in your spleen. (Cycles 1 and 2 only)
On Day 28 of cycles 1,2,3 and every third cycle (Cycle 6, 9, and so on), the following tests and procedures will be performed:
- You will have a physical exam, including measurement of yur vital signs and weight.
- Measurements of your spleen and/or liver will be taken.
- You will have a performance status evaluation.
On Day 28 of every sixth cycle (Cycle 6, 12 and so on)the following tests and procedures will be performed:
- Blood (about 4 teaspoons) will be drawn to test your thyroid function.
- You will have an ECG.
- Response of disease to therapy will be assessed. Bone marrow biopsy and aspirate will be done to confirm a complete response if your doctor thinks it is needed.
Pregnancy Testing:
Women who are able to have children will have a pregnancy test every week during Cycle 1, and then every 28 days after that if your menstrual cycle is regular (If your menstrual cycle is not regular, you will have a blood pregnancy test every 2 weeks). These pregnancy tests will be part of a routine blood draw.
Length of Study:
You will remain on study treatment as long as the therapy is beneficial to you. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurements of your vital signs and measurements of your spleen and/or liver.
- You will have an ECG.
- You will be asked about any drugs you are taking and about any blood transfusions you may have had.
- Blood (about 4 tablespoons) and urine will be collected for routine tests and thyroid function tests. This routine blood draw will include a pregnancy test for women who are able to have children.
- You will be asked about any side effects you may have experienced.
Follow-Up Visit:
Women who are able to have children will have a blood (about 1 tablespoon) pregnancy test 28 days after the last dose of study drug. If your periods are irregular you will have 2 blood (about 1 tablespoon each time) pregnancy tests, one 14 days after the last dose of study drug and another 28 days after the last dose of study drug. Response of disease to therapy will be assessed at follow-up 28 days after last dose of study drug.
This is an investigational study. CC-4047 (pomalidomide) is FDA approved and commercially available for the treatment of certain types of MM. Its use in this study is investigational.
Prednisone is FDA approved and commercially available.
Up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Polycythemia Vera, Thrombocythemia
- Being tested
- CC-4047, Prednisone
- Keywords
- CC-4047, Pomalidomide, polycythemia vera, essential thrombocythemia myelofibrosis
- Medical subject headings
- Polycythemia Vera, Thrombocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-4047Drug
Also called Pomalidomide
0.5 mg capsules daily by mouth day 1 through day 28.
PrednisoneDrug
30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
CC-4047Drug
Also called Pomalidomide
3.0 mg capsules daily by mouth day 1 through 21.
| Study group | Role | What they receive |
|---|---|---|
| Group 3 CC-4047 + Prednisone | Experimental | CC-4047 0.5 mg orally daily starting on day 1 through 28. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued. Receives: Drug: CC-4047; Drug: Prednisone |
| Group 1 CC-4047 | Experimental | CC-4047 3.0 mg orally daily starting on day 1 through 21. Receives: Drug: CC-4047 |
| Group 2 CC-4047 | Experimental | CC-4047 0.5 mg orally daily starting on day 1 through 28. Receives: Drug: CC-4047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Best Overall Response
Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study start22 Jul 2009
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first 21 participants received pomalidomide 3.0 mg/day on a 21 day schedule. Due to poor tolerance the study was suspended and amended to treat 20 participants with pomalidomide 0.5 mg/day continuously for 28 days. The study was amended to treat an additional 29 participants with pomalidomide 0.5 mg/day for 28 days plus prednisone.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Srdan Verstovsek, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946270
- Sponsor's protocol ID
- 2007-0199
- Other IDs
- NCI-2012-00360
- Status last verified
- Jun 2019
- First submitted
- 23 Jul 2009
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Daver N, Shastri A, Kadia T, Newberry K, Pemmaraju N, Jabbour E, Zhou L, Pierce S, Cortes J, Kantarjian H, Verstovsek S. Phase II study of pomalidomide in combination with prednisone in patients with myelofibrosis and significant anemia. Leuk Res. 2014 Sep;38(9):1126-9. doi: 10.1016/j.leukres.2014.06.015. Epub 2014 Jul 6.
PubMed 25047979Daver N, Shastri A, Kadia T, Quintas-Cardama A, Jabbour E, Konopleva M, O'Brien S, Pierce S, Zhou L, Cortes J, Kantarjian H, Verstovsek S. Modest activity of pomalidomide in patients with myelofibrosis and significant anemia. Leuk Res. 2013 Nov;37(11):1440-4. doi: 10.1016/j.leukres.2013.07.007. Epub 2013 Jul 25.
PubMed 23890523
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Open Label Study (PO-MMM-PI-0011) to Determine the Safety and Efficacy of Pomalidomide (CC-4047) in Subjects With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, or Post-ET MF)
- ClinicalTrials.gov ID
- NCT00946270
- Acronym / sponsor ID
- 2007-0199
- Conditions
- Polycythemia Vera, Thrombocythemia
- Keywords
- CC-4047, Pomalidomide, polycythemia vera, essential thrombocythemia myelofibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 22 Jul 2009 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and prednisone can help to control MMM. The safety of this therapy will also be studied.
Detailed description
The Study Drug:
CC-4047 is a drug that may also affect the growth of blood vessels that support tumor growth. If these blood vessels stop growing, it may stop cancer cell growth.
Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with other chemotherapy to treat cancer.
Study Drug Administration:
On Days 1- 28 of every 28-day study "cycle," you will take CC-4047 capsule(s) by mouth. You should take the capsule(s), about the same time every day. The capsule(s) should not be opened, broken, or chewed. CC-4047 should be taken without food, at least 2 hours before or 2 hours after a meal. If a dose of CC-4047 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, rather it should be taken at the next scheduled time point.
In order to take part in this study, you must register into and follow the requirements of the POMALYST REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of exposing unborn children to the study drug, and the risks of blood clots and reduced blood counts. You will be required to receive counseling, follow the pregnancy testing and birth control requirements of the program that are appropriate for you, and take surveys regarding how well you are following with the POMALYST REMS™ program.
You will receive prednisone by mouth during the first 3 cycles of therapy. You will take it 1 time a day during Cycle 1. During Cycle 2, you will take a smaller dose 1 time a day. During Cycle 3, you will take the same dose as in Cycle 2, but only 1 time every other day.
On Days 1-28, you will also take low-dose aspirin. This should be taken at the same time as CC-4047. Aspirin is take to help prevent blood clots, which may occur from taking CC-4047. If you are unable to take aspirin, your study doctor will have you take another drug.
You will be given a study "diary". In this diary, you will record when you take each dose of the study drug. You will return any unused study drug and empty bottles at each visit.
Study Visits:
On Day 1 of Cycles 1 and 2, the following tests and procedures will be performed:
- You will have a physical exam, including measurements of your vital signs (blood pressure, temperature, and heart rate) and weight.
- You will be asked about any drugs you are taking and about recent blood transfusions you may have had.
- You will have a performance status evaluation.
- Blood (about 1 tablespoon) will be drawn for routine tests.
On Days 1, 8, 15, and 22 of Cycles 1 and 2, blood (about 4 teaspoons) will be drawn for routine tests.
On Day 28 of each cycle, the following tests and procedures will be performed:
- You will be asked about any drugs you are taking and about recent blood transfusions you may have had.
- You will be asked about any birth control methods you are using.
- Blood (about 4 tablespoons) will be drawn for routine tests.
- You will be asked about any new side effects or medical conditions you may have experienced.
- You will complete a questionnaire about your quality-of-life as well as an assessment of possible pain in your spleen. (Cycles 1 and 2 only)
On Day 28 of cycles 1,2,3 and every third cycle (Cycle 6, 9, and so on), the following tests and procedures will be performed:
- You will have a physical exam, including measurement of yur vital signs and weight.
- Measurements of your spleen and/or liver will be taken.
- You will have a performance status evaluation.
On Day 28 of every sixth cycle (Cycle 6, 12 and so on)the following tests and procedures will be performed:
- Blood (about 4 teaspoons) will be drawn to test your thyroid function.
- You will have an ECG.
- Response of disease to therapy will be assessed. Bone marrow biopsy and aspirate will be done to confirm a complete response if your doctor thinks it is needed.
Pregnancy Testing:
Women who are able to have children will have a pregnancy test every week during Cycle 1, and then every 28 days after that if your menstrual cycle is regular (If your menstrual cycle is not regular, you will have a blood pregnancy test every 2 weeks). These pregnancy tests will be part of a routine blood draw.
Length of Study:
You will remain on study treatment as long as the therapy is beneficial to you. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of-Treatment Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurements of your vital signs and measurements of your spleen and/or liver.
- You will have an ECG.
- You will be asked about any drugs you are taking and about any blood transfusions you may have had.
- Blood (about 4 tablespoons) and urine will be collected for routine tests and thyroid function tests. This routine blood draw will include a pregnancy test for women who are able to have children.
- You will be asked about any side effects you may have experienced.
Follow-Up Visit:
Women who are able to have children will have a blood (about 1 tablespoon) pregnancy test 28 days after the last dose of study drug. If your periods are irregular you will have 2 blood (about 1 tablespoon each time) pregnancy tests, one 14 days after the last dose of study drug and another 28 days after the last dose of study drug. Response of disease to therapy will be assessed at follow-up 28 days after last dose of study drug.
This is an investigational study. CC-4047 (pomalidomide) is FDA approved and commercially available for the treatment of certain types of MM. Its use in this study is investigational.
Prednisone is FDA approved and commercially available.
Up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The first 21 participants received pomalidomide 3.0 mg/day on a 21 day schedule. Due to poor tolerance the study was suspended and amended to treat 20 participants with pomalidomide 0.5 mg/day continuously for 28 days. The study was amended to treat an additional 29 participants with pomalidomide 0.5 mg/day for 28 days plus prednisone.
| Arm | Type | Receives |
|---|---|---|
| Group 3 CC-4047 + Prednisone | Experimental | Drug: CC-4047, Drug: PrednisoneCC-4047 0.5 mg orally daily starting on day 1 through 28. Prednisone given during first 3 cycles of therapy. It will be dosed orally at the dose of 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued. |
| Group 1 CC-4047 | Experimental | Drug: CC-4047CC-4047 3.0 mg orally daily starting on day 1 through 21. |
| Group 2 CC-4047 | Experimental | Drug: CC-4047CC-4047 0.5 mg orally daily starting on day 1 through 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be >/= 18 years of age at the time of voluntarily signing an Institutional Review Board/Independent Ethics Committee (IRB/IEC) - approved informed consent form.
- Must be diagnosed with myelofibrosis requiring therapy including myelofibrosis with myeloid metaplasia (MMM), de novo presentation (i.e. agnogenic myeloid metaplasia [AMMM], and developing after an antecedent history of Polycythemia vera (i.e., post-polycythemic myeloid metaplasia [PPMM]), or essential Polycythemia (i.e., post thrombocythemic myeloid metaplasia [PTMM]).
- Screening total hemoglobin level < 10 g/dL or transfusion-dependent anemia defined as per International Working Group (IWG) criteria (transfusion dependency defined by a history of a least 2 units of red blood cell transfusions in the last 28 days for hemoglobin < 8.5 g/dL that was not associated with overt bleeding)
- Must have adequate organ function as demonstrated by the following </= 14 days prior to starting study drug: ·Alanine transaminase (ALT) (SGOT) and Aspartate aminotransferase (AST) (SGPT) </= 3 x upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH)] ·Total bilirubin < 3 x ULN or Direct Bilirubin < 2 x ULN ·Serum creatinine </= 2.5 mg/dL ·Absolute neutrophil count >/= 1,000/µL (>/=1.0 x 10^9/L) ·Platelet count >/= 50,000/µL (>/=50 x 10^9/L)
- Subjects must be willing to receive transfusion of blood products
Key exclusion criteria (6 listed)
- Known positive status for HIV, hepatitis B carrier, or active hepatitis C infection.
- The use of any growth factors, cytotoxic chemotherapeutic agents (e.g. hydroxyurea), corticosteroids, or experimental drug or therapy within 14 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.
- Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or lactating females
- Prior use of CC-4047
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-4047Also: Pomalidomide0.5 mg capsules daily by mouth day 1 through day 28. | Drug | Group 2 CC-4047, Group 3 CC-4047 + Prednisone |
| Prednisone30 mg by mouth daily during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued. | Drug | Group 3 CC-4047 + Prednisone |
| CC-4047Also: Pomalidomide3.0 mg capsules daily by mouth day 1 through 21. | Drug | Group 1 CC-4047 |
Primary outcome
Number of Participants With Best Overall Response
Time frame: 6 months
Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25047979Daver N, Shastri A, Kadia T, Newberry K, Pemmaraju N, Jabbour E, Zhou L, Pierce S, Cortes J, Kantarjian H, Verstovsek S. Phase II study of pomalidomide in combination with prednisone in patients with myelofibrosis and significant anemia. Leuk Res. 2014 Sep;38(9):1126-9. doi: 10.1016/j.leukres.2014.06.015. Epub 2014 Jul 6.
- Derived from this study: PubMed 23890523Daver N, Shastri A, Kadia T, Quintas-Cardama A, Jabbour E, Konopleva M, O'Brien S, Pierce S, Zhou L, Cortes J, Kantarjian H, Verstovsek S. Modest activity of pomalidomide in patients with myelofibrosis and significant anemia. Leuk Res. 2013 Nov;37(11):1440-4. doi: 10.1016/j.leukres.2013.07.007. Epub 2013 Jul 25.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srdan Verstovsek, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-4047 and Prednisone in people with Polycythemia Vera and Thrombocythemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Best Overall Response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.