LeukemiaPhase 2NCT01893372
Eltrombopag With or Without Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Eltrombopag and Hypomethylating Agent (HMA) in people with Leukemia, 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 eltrombopag can help to control MDS. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Eltrombopag and Hypomethylating Agent (HMA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 6 Jan 2019
- 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
- Signed, informed consent must be obtained prior to any study specific procedures.
- Subjects with a histologically confirmed diagnosis of MDS by FAB criteria, including both MDS and RAEB-T (AML with 20-30% blasts and multilineage dysplasia) by World Health Organization (WHO) classification are eligible.
- Patients must have completed at least 4 cycles of hypomethylating agent therapy (e.g azacitidine or decitabine) with failure to achieve at least a partial response, or with the presence of ongoing cytopenias per International Working Group (IWG) (platelet count < 100x10^9/L, hemoglobin <11g/L or Absolute Neutrophil Count (ANC) <1x10^9/L). Patients with progressive disease on HMA-therapy prior to this time point are also eligible at the time of documented progression. Therapy with decitabine analogs (i.e. SGI-110) will be considered as decitabine for the purposes of this study.
- Platelet count <100x10^9/L
- Low, intermediate-1, intermediate-2 or High-risk category by International Prognostic Scoring System (IPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
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- Adequate liver function, as evidenced by a serum bilirubin </=2x the ULN (except for patients with a confirmed diagnosis of Gilbert's Disease) and an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) </=3x the laboratory Upper Limit of Normal (ULN).
- Serum creatinine </=2x upper limit of normal
- Subjects must be>/= 18 years of age at the time of informed consent, because no dosing or adverse event data are currently available on the use of eltrombopag in children.
- Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Male partner is sterile prior to entry into the study and is the only partner of the female; - Systemic contraceptives (combined or progesterone only).
- Patients must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment. Treatment may start earlier if necessitated by the patient's medical condition (e.g. progressive disease) following discussion with the Investigator.
Who cannot join
- Subjects with any prior exposure to a thrombopoietin-receptor agonist
- Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
- Active uncontrolled serious infection or sepsis at study enrollment
- Clinically significant gastrointestinal disorders that may interfere with absorption of drug.
- History of arterial thrombosis (i.e. stroke) in the past year
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- History of venous thrombosis currently requiring anti-coagulation therapy
- Unstable angina, congestive heart failure (New York Heart Association (NYHA) > Class II), uncontrolled hypertension (diastolic blood pressure > 100mmHg), or recent (within 1 year) myocardial infarction
- Subjects with a QTc > 480 msec (QTc > 510 msec for subjects with Bundle Branch Block) at baseline
- Pregnant or breast-feeding because there are no adequate and well-controlled studies of eltrombopag use in pregnancy and it is unknown whether eltrombopag is excreted in human milk.
- Subjects with known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), because eltrombopag is hepatically cleared, and underlying hepatic impairment may lead to an increased risk of hepatotoxicity. Eltrombopag has not been evaluated with combination antiretroviral regimens.
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: Phase II Study of Eltrombopag With or Without Continuation of Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if eltrombopag can help to control MDS. The safety of this drug will also be studied.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 arms.The selection of treatment arm will be made by you and your treating physician.
- If you are in Arm A, you will receive eltrombopag alone.
- If you are in Arm B, you will receive eltrombopag and will continue to receive the hypomethylating agent that you were receiving before you took part in this study.
Study Drug Administration:
You will take eltrombopag by mouth every day of each 28-day study cycle. If you are in Arm B, you will also continue to take the hypomethylating agent you took before joining the study at the same dosing schedule you were receiving before entering this study.
Eltrombopag should be taken on an empty stomach (1 hour before or 2 hours after a meal). Do not eat calcium-rich foods (such as dairy products and calcium fortified juices), or take other drugs (such as antacids) or supplements containing iron, calcium, aluminum, magnesium, selenium, and/or zinc for 2 hours before or 4 hours after taking eltrombopag. If a dose of eltrombopag is vomited, it should not be made up or re-taken on the same day. If the morning dose is missed, it may be taken up until 5:00 PM on the same day.
Study Visits:
On Day 1 of all Cycles:
- You will have a physical exam including vital signs.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 8, 15, and 22 of Cycle 1:
- Your vital signs (blood pressure, heart rate, and temperature) will be measured.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
If the doctor thinks it is needed, on Day 1 of every 3 cycles (Cycles 3, 6, 9, and so on), you will also have a bone marrow aspirate/biopsy to check the status of the disease and for cytogenetic testing.
Length of Study:
You may continue taking the study drug(s) for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) 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 the follow-up visits.
End-of-Treatment Visit:
Within 5 days of your last dose of study drug, you will come to the clinic for an end-of-treatment visit. The following procedures will be performed:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- You may have a bone marrow aspirate/biopsy collected to check the status of the disease and for cytogenetic testing.
Follow-up Visit:
About 28 days after your last dose of study drug, you will come to the clinic for a follow-up visit. the following procedures will be performed:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Its use in this study is investigational. Azacitidine and decitabine are each FDA approved for the treatment of MDS and are commercially available. The study doctor can explain how the study drug(s) are designed to work.
Up to 46 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Eltrombopag, Hypomethylating Agent (HMA)
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, Overall response rate, ORR, Eltrombopag, Promacta, Hypomethylating Agent
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Also called Promacta
200 mg by mouth daily in a 28 day cycle.
Hypomethylating Agent (HMA)Drug
The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study.
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | Eltrombopag 200 mg by mouth daily in a 28 day cycle. Receives: Drug: Eltrombopag |
| Eltrombopag + Hypomethylating Agent (HMA) | Experimental | Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle.
The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent. Receives: Drug: Eltrombopag; Drug: Hypomethylating Agent (HMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI). Patients' overall response assessed after at least 2 cycles of treatment and no more than after 6 cycles of treatment and each cycle is 28 days. CR is Bone marrow of </= 5% myeloblasts with normal maturation of cell lines, persistent dysplasia and a hemoglobin >/= 11g/dl, platelets >/= 100x10^9/L, neutrophils >/= 1.0x10^9/L and 0% blasts. PR is the same as CR but bone marrow blasts decreased by >/=50% but still 5% over pre-treatment. HI is described by the number of individually affected cell lines. (E = Erythroid, N = Neutrophils, P = Platelet). HI-E is a 2 gram increase in hemoglobin. HI-N is at least a 100% increase or an absolute increase of more than 500/mm^3. HI-P is an absolute increase of 30/mm^3 or a 50% increase
Measured: After second 28 day cycle
Overall Survival (OS)
Overall Survival (OS) was measured from the time of study enrollment until death from any cause or fate of the last follow-up.
Measured: Through study completion. Up to 3 years, 3 months.
Secondary outcomes (2)
Number of Participants Transforming From Myelodysplastic Syndrome (MDS) to Acute Myeloid Leukemia (AML)
Measured: Up to 3 years, 3 months.
Number of Participants Achieving a Platelet Response
Platelet response is Hematologic Improvement with platelet response (HI-P), defined as an absolute increase of >/= 30 x 10^9/L for patients starting with >20 x 10^9/L platelets or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startOct 2013
- Primary completion6 Jan 2019
- Study completion6 Jan 2019
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.
- Other trials for LeukemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Novartis
- Responsible party
- Sponsor
- Investigators
- Courtney DiNardo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893372
- Sponsor's protocol ID
- 2013-0225
- Other IDs
- NCI-2013-02252
- Status last verified
- Feb 2020
- First submitted
- 2 Jul 2013
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Eltrombopag With or Without Continuation of Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01893372
- Acronym / sponsor ID
- 2013-0225
- Conditions
- Leukemia
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, Overall response rate, ORR, Eltrombopag, Promacta, Hypomethylating Agent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Novartis
- Study start
- Oct 2013 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 6 Jan 2019 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Posted 18 Feb 2020
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 eltrombopag can help to control MDS. The safety of this drug will also be studied.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 arms.The selection of treatment arm will be made by you and your treating physician.
- If you are in Arm A, you will receive eltrombopag alone.
- If you are in Arm B, you will receive eltrombopag and will continue to receive the hypomethylating agent that you were receiving before you took part in this study.
Study Drug Administration:
You will take eltrombopag by mouth every day of each 28-day study cycle. If you are in Arm B, you will also continue to take the hypomethylating agent you took before joining the study at the same dosing schedule you were receiving before entering this study.
Eltrombopag should be taken on an empty stomach (1 hour before or 2 hours after a meal). Do not eat calcium-rich foods (such as dairy products and calcium fortified juices), or take other drugs (such as antacids) or supplements containing iron, calcium, aluminum, magnesium, selenium, and/or zinc for 2 hours before or 4 hours after taking eltrombopag. If a dose of eltrombopag is vomited, it should not be made up or re-taken on the same day. If the morning dose is missed, it may be taken up until 5:00 PM on the same day.
Study Visits:
On Day 1 of all Cycles:
- You will have a physical exam including vital signs.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 8, 15, and 22 of Cycle 1:
- Your vital signs (blood pressure, heart rate, and temperature) will be measured.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
If the doctor thinks it is needed, on Day 1 of every 3 cycles (Cycles 3, 6, 9, and so on), you will also have a bone marrow aspirate/biopsy to check the status of the disease and for cytogenetic testing.
Length of Study:
You may continue taking the study drug(s) for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) 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 the follow-up visits.
End-of-Treatment Visit:
Within 5 days of your last dose of study drug, you will come to the clinic for an end-of-treatment visit. The following procedures will be performed:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- You may have a bone marrow aspirate/biopsy collected to check the status of the disease and for cytogenetic testing.
Follow-up Visit:
About 28 days after your last dose of study drug, you will come to the clinic for a follow-up visit. the following procedures will be performed:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Its use in this study is investigational. Azacitidine and decitabine are each FDA approved for the treatment of MDS and are commercially available. The study doctor can explain how the study drug(s) are designed to work.
Up to 46 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: EltrombopagEltrombopag 200 mg by mouth daily in a 28 day cycle. |
| Eltrombopag + Hypomethylating Agent (HMA) | Experimental | Drug: Eltrombopag, Drug: Hypomethylating Agent (HMA)Eltrombopag in combination with continuation of hypomethylating agent in 28-day cycles. Eltrombopag 200 mg by mouth daily in a 28 day cycle. The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. Eltrombopag should be initiated at the start of the next HMA cycle whenever possible so the start date of both agents is consistent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed, informed consent must be obtained prior to any study specific procedures.
- Subjects with a histologically confirmed diagnosis of MDS by FAB criteria, including both MDS and RAEB-T (AML with 20-30% blasts and multilineage dysplasia) by World Health Organization (WHO) classification are eligible.
- Patients must have completed at least 4 cycles of hypomethylating agent therapy (e.g azacitidine or decitabine) with failure to achieve at least a partial response, or with the presence of ongoing cytopenias per International Working Group (IWG) (platelet count < 100x10^9/L, hemoglobin <11g/L or Absolute Neutrophil Count (ANC) <1x10^9/L). Patients with progressive disease on HMA-therapy prior to this time point are also eligible at the time of documented progression. Therapy with decitabine analogs (i.e. SGI-110) will be considered as decitabine for the purposes of this study.
- Platelet count <100x10^9/L
- Low, intermediate-1, intermediate-2 or High-risk category by International Prognostic Scoring System (IPSS)
Key exclusion criteria (11 listed)
- Subjects with any prior exposure to a thrombopoietin-receptor agonist
- Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
- Active uncontrolled serious infection or sepsis at study enrollment
- Clinically significant gastrointestinal disorders that may interfere with absorption of drug.
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 |
|---|---|---|
| EltrombopagAlso: Promacta200 mg by mouth daily in a 28 day cycle. | Drug | Eltrombopag, Eltrombopag + Hypomethylating Agent (HMA) |
| Hypomethylating Agent (HMA)The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study. | Drug | Eltrombopag + Hypomethylating Agent (HMA) |
Primary outcome
Overall Response Rate (ORR)
Time frame: After second 28 day cycle
Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI). Patients' overall response assessed after at least 2 cycles of treatment and no more than after 6 cycles of treatment and each cycle is 28 days. CR is Bone marrow of </= 5% myeloblasts with normal maturation of cell lines, persistent dysplasia and a hemoglobin >/= 11g/dl, platelets >/= 100x10^9/L, neutrophils >/= 1.0x10^9/L and 0% blasts. PR is the same as CR but bone marrow blasts decreased by >/=50% but still 5% over pre-treatment. HI is described by the number of individually affected cell lines. (E = Erythroid, N = Neutrophils, P = Platelet). HI-E is a 2 gram increase in hemoglobin. HI-N is at least a 100% increase or an absolute increase of more than 500/mm^3. HI-P is an absolute increase of 30/mm^3 or a 50% increase
Overall Survival (OS)
Time frame: Through study completion. Up to 3 years, 3 months.
Overall Survival (OS) was measured from the time of study enrollment until death from any cause or fate of the last follow-up.
2 secondary outcomes
Number of Participants Transforming From Myelodysplastic Syndrome (MDS) to Acute Myeloid Leukemia (AML)
Time frame: Up to 3 years, 3 months.
Number of Participants Achieving a Platelet Response
Time frame: 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Courtney DiNardo, 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 Eltrombopag and Hypomethylating Agent (HMA) in people with Leukemia, 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 11 inclusion and 11 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 18 Feb 2020. 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 18 Feb 2020). 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?
Overall Response Rate (ORR) (time frame: After second 28 day cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.