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NCT04708054 · ClinicalTrials.gov registry record · Phase 2

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS

A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
324
Enrollment target
1
Study location

NCT04708054 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 324 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (182% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04708054, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
324 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, 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. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia

Interventions

  • DRUG Busulfan
  • DRUG Cladribine
  • DRUG Thiotepa
  • DRUG Fludarabine Phosphate
  • PROCEDURE Hematopoietic Cell Transplantation

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2021-10-21
Est. Completion 2027-12-31
Phase Phase 2

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 NCT04708054

The ClinicalTrials.gov registry entry for NCT04708054 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (182% 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 Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Busulfan is the first listed.

NCT04708054 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04708054 about?

NCT04708054 is a clinical study titled "Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS". This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and f...

What is the current status of trial NCT04708054?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2021-10-21. Estimated completion is 2027-12-31.

What conditions does trial NCT04708054 study?

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

What interventions are being tested in trial NCT04708054?

The interventions under investigation include: Busulfan (DRUG), Cladribine (DRUG), Thiotepa (DRUG), Fludarabine Phosphate (DRUG), Hematopoietic Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT04708054?

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

Where is trial NCT04708054 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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