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NCT04266795 · ClinicalTrials.gov registry record · Phase 2

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

A Phase 2 study, sponsored by Takeda.

Completed
Registry status
Phase 2
Development phase
164
Enrollment target

NCT04266795 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 164 participants.

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The verdict

NCT04266795, a Phase 2 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 2
Development phase
164 participants
Enrollment target

Study Summary

The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Pevonedistat

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2020-10-13
Est. Completion 2025-10-06
Phase Phase 2

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT04266795

The ClinicalTrials.gov registry entry for NCT04266795 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.

NCT04266795 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04266795 about?

NCT04266795 is a clinical study titled "A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy". The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or vene...

What is the current status of trial NCT04266795?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2020-10-13. Estimated completion is 2025-10-06.

What interventions are being tested in trial NCT04266795?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Pevonedistat (DRUG).

Who is sponsoring clinical trial NCT04266795?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.