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

NCT03238248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-11-04

Study results available
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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.

Conditions

Interventions

DRUG

Azacitidine Subcutaneous Injection or Intravenous Infusion

75 mg/m2

DRUG

Pevonedistat Infusion

20 mg/m2

PROCEDURE

Bone Marrow Biopsy & Aspirate

Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Sanjay Mohan, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2022-09-30
Completion
2023-11-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238248 on ClinicalTrials.gov