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NCT03214562 · ClinicalTrials.gov registry record · Phase 1

Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia

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

Recruiting
Registry status
Phase 1
Development phase
116
Enrollment target
1
Study location

NCT03214562 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 116 participants, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (152% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03214562, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
116 participants
Enrollment target
1
Study location

Study Summary

This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia High Risk Myelodysplastic Syndrome

Interventions

  • DRUG Fludarabine
  • DRUG Cytarabine
  • DRUG Idarubicin
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL Pegfilgrastim

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2017-09-26
Est. Completion 2027-09-30
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT03214562

The ClinicalTrials.gov registry entry for NCT03214562 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (152% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.

NCT03214562 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03214562 about?

NCT03214562 is a clinical study titled "Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia". This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may st...

What is the current status of trial NCT03214562?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2017-09-26. Estimated completion is 2027-09-30.

What conditions does trial NCT03214562 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome.

What interventions are being tested in trial NCT03214562?

The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT03214562?

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

Where is trial NCT03214562 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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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.