Myelodysplastic SyndromesPhase 2NCT03238248
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
A Phase 2 study testing Azacitidine Subcutaneous Injection or Intravenous Infusion, Pevonedistat Infusion and Bone Marrow Biopsy & Aspirate in people with Myelodysplastic Syndromes and Myeloproliferative Neoplasm, run by Vanderbilt-Ingram Cancer Center at 5 sites in United States.
Trial summary
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- What is being tested?
- Azacitidine Subcutaneous Injection or Intravenous Infusion, Pevonedistat Infusion and Bone Marrow Biopsy & Aspirate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2017to 27 Nov 2023
- 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 and dated voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Male or female ≥ 18 years of age.
- Morphologically confirmed diagnosis of MDS or MDS/MPN in accordance with WHO diagnostic criteria.
- ECOG performance status of 0, 1 or 2.
- Expected survival ≥ 3 months after consenting.
- Refractory/relapsed disease following DNMTi failure. Refractory disease defined as either:
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- failure to achieve an objective response after at least 4 cycles of DNMTi therapy, or
- failure to achieve an objective response with clear progressive disease on bone marrow biopsy after at least 2 cycles of DNMTi therapy. Relapsed disease is defined as having progressive disease after achieving an objective response after at least 2 cycles of DNMTi therapy.
- Previous DNMTi therapy may include 5'azacitidine, decitabine, or DNMTi therapy currently in clinical trials (e.g. SGI-110 (guadecitabine), ASTX727 or CC-486).To be considered DNMTi treatment failure, during each prior treatment cycle, patients must have received equivalent to minimum dosing of:
- decitabine 15mg/m2 daily x 5 days, or
- 5'azacitidine 50mg/m2 IV/SC daily x 5 days,
- SGI-110 (guadecitabine) 60mg/m2 SC daily x 5 days, or
- oral DNMTi therapy with ASTX727 20/100mg daily x 5 days, or
- oral DNMTi therapy with CC-486 200mg daily x 14 days
- Recovery to ≤ Grade 1 or baseline of any toxicity due to prior systemic treatments, excluding alopecia.
- Patient consent to collection of fresh bone marrow biopsy and aspirate for exploratory research obtained from a procedure performed no more than 28 days prior to initiating treatment on Cycle 1, Day 1. Requirement for bone marrow biopsy may be waived with approval of the study chair in the event that a bone marrow biopsy cannot be obtained.
- Clinical laboratory values as specified below:
- Serum albumin > 2.7 g/dL
- Total bilirubin ≤ 1.5 x ULN
- ALT and AST ≤ 2 x ULN
- Calculated creatinine clearance ≥ 50 mL/min (per the Cockcroft-Gault formula)
- WBC ≤ 50,000/µL (use of hyroxyurea is permitted)
- Hgb <8g/dL should be transfused to provide adequate tissue perfusion as per the discretion of the investigators and local practice. Rechecking Hgb level prior to start on Cycle 1 Day 1 is not necessary as long as patients do not have inadequate oxygenation, underlying cardiopulmonary compromise, and/or any other reason deemed clinically significant to delay therapy per the investigator.
- Women of childbearing potential must have a negative serum pregnancy test; and additionally agree to simultaneously use at least 2 methods of effective contraception or abstain from heterosexual intercourse from the time of signing consent, and until 4 months after patient's last dose of protocol-indicated treatment. Periodic abstinence (e.g. calendar,ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception.
- Women of child bearing potential are defined as those not surgically sterile or not post-menopausal. If a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for at least 1 year in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential. Postmenopausal status in females under 55 years of age should be confirmed with a serum FSH level within laboratory reference range for postmenopausal women.
- Men, even if surgically sterilized (i.e. status post-vasectomy), who are sexually active with women of childbearing potential must agree to follow instructions for effective barrier contraception from the time of signing consent and until 4 months after last dose of protocol-indicated treatment. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Diagnosis of acute myeloid leukemia (i.e. ≥ 20% peripheral or marrow blasts).
- Any HSCT within 6 months prior to signing informed consent.
- Any patient who is eligible for HSCT at the time of study screening.
- Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non-hematologic toxicity related to HSCT
- Any previous treatment with pevonedistat or other NEDD8 inhibitor.
- Treatment with any investigational products within 14 days before the first dose of protocol-indicated treatment.
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- Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of any study drug.
- Major surgery requiring general anesthesia within 14 days before the first dose of any study drug or a scheduled surgery during study period. (Placement of a central line or port-a-catheter is acceptable within this time frame and does not exclude the patient.)
- Treatment with clinically significant metabolic CYP3A inducers within 14 days before the first dose of study drug. Clinically significant CYP3A inducers are not permitted during the study.
- Prolonged QTc interval > 500 msec, calculated according to Fredericia's formula
- Known cardiopulmonary disease defined as having one or more of the following:
- Uncontrolled high blood pressure (i.e. systolic > 180 mmHg or diastolic > 95 mmHg);
- Symptomatic cardiomyopathy;
- Ischemic heart disease; Patients with acute coronary syndrome, myocardial infarction, and/or revascularization (e.g. coronary artery bypass graft, stent) within 6 months of first dose of study drug are excluded; Patients with a history of ischemic heart disease who have had revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll;
- Arrhythmia (e.g. history of polymorphic ventricular fibrillation or torsade de pointes). Patients with symptomatic atrial fibrillation (Afib) incompletely controlled medically, or controlled by device (e.g. pacemaker) or by ablation in the past 6 months are excluded. However, patients with stable, AFib for a period of at least 6 months, whose Afib is controlled with medication, or who have a history of paroxysmal AFib are permitted to enroll;
- Implantable cardioverter defibrillator;
- Congestive heart failure (New York Heart Association [NYHA] Class III or IV; or Class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening),
- Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing). Mild regurgitation is not excluded;
- Pulmonary hypertension.
- Female patients who are both lactating and breastfeeding, who have a positive serum pregnancy test during screening, or who plan to become pregnant while in the trial or within 90 days after receiving protocol-directed treatment.
- Active uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are not excluded.
- Known Childs class B or C hepatic cirrhosis or severe pre-existing hepatic impairment.
- Known hepatitis B surface antigen seropositivity or known or suspected active hepatitis C infection. Note: Patients who have isolated positive hepatitis B core antibody (i.e. in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
- Known human immunodeficiency virus (HIV) seropositivity.
- Any serious concurrent condition that could, in the investigator's opinion, significantly interfere with completion of study procedures or protocol compliance.
- Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).
- Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Miami Miller School of Medicine
Miami, Florida, 33136
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan-Kettering
New York, New York, 10065
University of Rochester Medical Center
Rochester, New York, 14642
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: A Phase II Trial of Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
Read the detailed description
Primary Objective:
To compare survival of patients treated with a combination of pevonedistat and azacitidine after failure of DNA methyltransferase inhibitors (DNMTi) to historical survival for patients with relapsed/refractory myelodysplastic syndrome (MDS) or myelodysplastic/ myeloproliferative overlap syndromes (MDS/MPN) who are ineligible for hematopoietic stem cell transplant (HSCT)
Secondary Objectives:
- To determine the rate of hematologic improvement (HI) in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
- To determine the complete remission (CR) and marrow CR rates in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
- To determine the reduction of bone marrow blasts in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
Exploratory Objectives:
- To correlate the mutation burden in patients with relapsed/refractory MDS or MDS/MPN with response to treatment with pevonedistat and azacitidine
- To correlate genomic aberrations with rate of response and survival in relapsed/refractory MDS or MDS/MPN patients treated with pevonedistat and azacitidine
- To measure the effect of pevonedistat treatment in combination with azacitidine on quality of life in patients with relapsed/refractory MDS or MDS/MPN
- To define epigenetic biomarkers for pevonedistat use in relapsed/refractory MDS or MDS/MPN
- Being tested
- Azacitidine Subcutaneous Injection or Intravenous Infusion, Pevonedistat Infusion, Bone Marrow Biopsy & Aspirate
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine Subcutaneous Injection or Intravenous InfusionDrug
75 mg/m2
Pevonedistat InfusionDrug
20 mg/m2
Bone Marrow Biopsy & AspirateProcedure or surgery
Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
| Study group | Role | What they receive |
|---|---|---|
| Pevonedistat and Azacitidine | Experimental | Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle. Receives: Drug: Azacitidine Subcutaneous Injection or Intravenous Infusion; Drug: Pevonedistat Infusion; Procedure: Bone Marrow Biopsy & Aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survial Time
Overall survival time is defined as time from day 1 in cycle 1 to death for any reason. Patiens alive at last follow up were censored. Overall survival time will be summarized using the method of Kaplan and Meier.
Measured: up to 2 years after treatment, a maximum possible duration of 38 months.
Secondary outcomes (3)
Time to Progression
Progression-free survival time is defined as time from day1 in cycle 1 to progression or death. Those alive without progression at the last follow up were censored. This survival will be summarized using the method of Kaplan and Meier.
Measured: Up to 24 months, or death
Objective Response Rate
Objective response rate is defined as the percentage of patients with best response of Complete remission (CR), Hematologic improvement (HI), Marrow CR (mCR), or Partial remission (PR) among all patients evaluated. The other categories of response are progressive disease, stable disease and inevaluable. The modified recommendations of the International Working Group (IWG) for Response Criteria for altering natural history of MDS , as well as the International Consortium of clinical experts in MDS/MPN devised uniform response criteria and criteria for disease progression in MDS/MPN overlap syndromes based on three independent academic MDS/MPN workshops (Marsh 2013, December 2013 and June 2014) were used for response assessment.
Measured: Up to 12 months
Rate of Hematologic Response Per IWG
Will assess complete and differential blood counts (peripheral blood), and transfusion requirements. The rate of hematologic improvement is defined as the percentage of patients with only hematologic improvement (defined in the protocol) among all patients evaluated for response.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start7 Aug 2017
- Primary completion30 Sep 2022
- Study completion27 Nov 2023
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 Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sanjay Mohan, Vanderbilt-Ingram Cancer Center
- Investigators
- Sanjay Mohan, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238248
- Sponsor's protocol ID
- VICC HEM 16146
- Other IDs
- NCI-2017-01377
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2017
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
- ClinicalTrials.gov ID
- NCT03238248
- Acronym / sponsor ID
- VICC HEM 16146
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
Detailed description
Primary Objective:
To compare survival of patients treated with a combination of pevonedistat and azacitidine after failure of DNA methyltransferase inhibitors (DNMTi) to historical survival for patients with relapsed/refractory myelodysplastic syndrome (MDS) or myelodysplastic/ myeloproliferative overlap syndromes (MDS/MPN) who are ineligible for hematopoietic stem cell transplant (HSCT)
Secondary Objectives:
- To determine the rate of hematologic improvement (HI) in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
- To determine the complete remission (CR) and marrow CR rates in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
- To determine the reduction of bone marrow blasts in patients with relapsed/refractory MDS or MDS/MPN treated with pevonedistat and azacitidine after DNMTi failure
Exploratory Objectives:
- To correlate the mutation burden in patients with relapsed/refractory MDS or MDS/MPN with response to treatment with pevonedistat and azacitidine
- To correlate genomic aberrations with rate of response and survival in relapsed/refractory MDS or MDS/MPN patients treated with pevonedistat and azacitidine
- To measure the effect of pevonedistat treatment in combination with azacitidine on quality of life in patients with relapsed/refractory MDS or MDS/MPN
- To define epigenetic biomarkers for pevonedistat use in relapsed/refractory MDS or MDS/MPN
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pevonedistat and Azacitidine | Experimental | Drug: Azacitidine Subcutaneous Injection or Intravenous Infusion, Drug: Pevonedistat Infusion, Procedure: Bone Marrow Biopsy & AspirateParticipants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle. Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Signed and dated voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Male or female ≥ 18 years of age.
- Morphologically confirmed diagnosis of MDS or MDS/MPN in accordance with WHO diagnostic criteria.
- ECOG performance status of 0, 1 or 2.
- Expected survival ≥ 3 months after consenting.
Key exclusion criteria (27 listed)
- Diagnosis of acute myeloid leukemia (i.e. ≥ 20% peripheral or marrow blasts).
- Any HSCT within 6 months prior to signing informed consent.
- Any patient who is eligible for HSCT at the time of study screening.
- Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non-hematologic toxicity related to HSCT
- Any previous treatment with pevonedistat or other NEDD8 inhibitor.
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 |
|---|---|---|
| Azacitidine Subcutaneous Injection or Intravenous Infusion75 mg/m2 | Drug | Pevonedistat and Azacitidine |
| Pevonedistat Infusion20 mg/m2 | Drug | Pevonedistat and Azacitidine |
| Bone Marrow Biopsy & AspirateRemoval of a small piece of bone and bone marrow by inserting a needle into hip bone. | Procedure or surgery | Pevonedistat and Azacitidine |
Primary outcome
Overall Survial Time
Time frame: up to 2 years after treatment, a maximum possible duration of 38 months.
Overall survival time is defined as time from day 1 in cycle 1 to death for any reason. Patiens alive at last follow up were censored. Overall survival time will be summarized using the method of Kaplan and Meier.
3 secondary outcomes
Time to Progression
Time frame: Up to 24 months, or death
Objective Response Rate
Time frame: Up to 12 months
Rate of Hematologic Response Per IWG
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Sanjay Mohan, MD principal investigator
Vanderbilt-Ingram Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine Subcutaneous Injection or Intravenous Infusion, Pevonedistat Infusion and Bone Marrow Biopsy & Aspirate in people with Myelodysplastic Syndromes and Myeloproliferative Neoplasm, run by Vanderbilt-Ingram Cancer Center at 5 sites 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 26 inclusion and 27 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 21 Nov 2023). 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 Survial Time (time frame: up to 2 years after treatment, a maximum possible duration of 38 months.). 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 4 Nov 2024.