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NCT03862157 · ClinicalTrials.gov registry record · Phase 1

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT03862157 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03862157, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Essential Thrombocythemia Myeloid Neoplasm Chronic Neutrophilic Leukemia Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Chronic Eosinophilic Leukemia, Not Otherwise Specified Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Pevonedistat

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-02-27
Est. Completion 2027-01-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03862157

The ClinicalTrials.gov registry entry for NCT03862157 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT03862157 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03862157 about?

NCT03862157 is a clinical study titled "Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of...

What is the current status of trial NCT03862157?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-02-27. Estimated completion is 2027-01-31.

What conditions does trial NCT03862157 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Essential Thrombocythemia, Myeloid Neoplasm.

What interventions are being tested in trial NCT03862157?

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

Who is sponsoring clinical trial NCT03862157?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03862157 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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