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DNA Methyltransferase Inhibitor

Pevonedistat + Azacitidine for Myelodysplastic Syndrome

Phase 2

Waitlist Available

Led By Michael Savona, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥ 18 years of age

Morphologically confirmed diagnosis of MDS or MDS/MPN in accordance with WHO diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after treatment, a maximum possible duration of 38 months.

Awards & highlights

Study Summary

This trial will test a new combination of drugs for patients with a certain type of blood cancer who have not responded to other treatments.

Who is the study for?

Adults with Myelodysplastic Syndrome or MDS/MPN who didn't respond to previous DNA methyltransferase inhibitor therapy can join. They should be expected to live at least 3 months, have a decent performance status, and recovered from past treatment side effects (except hair loss). Participants must consent to bone marrow biopsies and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the combination of Pevonedistat infusion and Azacitidine injection in patients whose conditions worsened despite prior treatments. It aims to see if this combo is effective after other therapies failed. Bone marrow samples will be collected for research purposes.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, kidney issues reflected by changes in urine output or swelling in legs, and potential liver abnormalities seen as jaundice or dark urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My condition is officially diagnosed as MDS or MDS/MPN.

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I can take care of myself and am up and about more than half of my waking hours.

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My condition did not improve after DNMTi treatment.

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I have recovered from previous cancer treatments, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after treatment, a maximum possible duration of 38 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after treatment, a maximum possible duration of 38 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after treatment, a maximum possible duration of 38 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survial Time

Secondary outcome measures

Objective Response Rate

Rate of Hematologic Response Per IWG

Time to Progression

Other outcome measures

Change in Allele Frequency Assessed by Next Generation Sequencing (NGS)

Change in Number of Mutations as Assessed by Next Generation Sequencing (NGS)

Rate of Marrow Complete Response (mCR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pevonedistat and AzacitidineExperimental Treatment3 Interventions

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.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,862 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,201 Total Patients Enrolled

Michael Savona, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center

4 Previous Clinical Trials

207 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications is Pevonedistat Infusion most often prescribed to treat?

"Pevonedistat Infusion is an effective treatment for malignant neoplasms and can also be used to alleviate 20-30% blasts, neutropenia/thrombocytopenia, as well as anemia."

Answered by AI

What is the scope of participant recruitment for this clinical trial?

"At this time, recruitment for the study has ceased. Initial posting on August 7th 2017 was followed by an edit on November 15th 2022. For those looking to take part in other trials, 474 studies are currently seeking patients with myelodysplastic syndromes and 181 Pevonedistat Infusion related medical experiments require participants."

Answered by AI

Is enrollment currently open for this project?

"As per the information hosted on clinicaltrials.gov, this particular medical trial is not recruiting participants at present. Initially posted on August 7th 2017 and last edited November 15th 2022, it appears to no longer be actively seeking enrolment; however there are still 655 other trials that are presently accepting applicants."

Answered by AI

What other experiments have been carried out utilizing Pevonedistat Infusion?

"The initial research of Pevonedistat Infusion was conducted in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. Since then, 170 trials have been successfully completed and a further 181 studies are currently recruiting participants, with Westwood, Kansas being the primary location for these protocols."

Answered by AI

How many venues are hosting this experiment?

"There are 5 major sites facilitating this clinical trial. These include University of Kansas Cancer Center in Westwood, Memorial Sloan-Kettering in New york and the University of Rochester Medical Centre in Rochester as well as a further 2 locations."

Answered by AI

Has Pevonedistat Infusion been given the regulatory nod by the FDA?

"There is basic data affirming Pevonedistat Infusion's safety, so it was rated a 2 on the 1 to 3 scale. However, there are yet no studies that demonstrate its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors

Michael Savona 2017. "Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03238248.

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