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NCT05554393 · ClinicalTrials.gov registry record · Phase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
A Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT05554393: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
NCT05554393 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 153 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05554393, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.
Primary Outcome
Will assess after one induction cycle with or without the addition of venetoclax or two cycles of venetoclax and azacitidine. MRD by flow cytometry will be considered undetectable if ≤ 10\^-3. The MRD negative CR will be assessed using European LeukemiaNet (ELN) 2017 criteria \[Döhner 2017\]. The analysis population for the primary outcome will be all randomized patients with the intent to treat population. The MRD undetectable CR rate will be the number of patients with MRD undetectable CR divi
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- DRUG Azacitidine
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
Study Locations (20)
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland - Fruitland
- Saint Luke's Cancer Institute - Meridian - Meridian
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Saint Luke's Cancer Institute - Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Cedars Sinai Medical Center - Los Angeles
- UCSF Medical Center-Parnassus - San Francisco
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Florida
- Miami Cancer Institute - Miami
- Memorial Hospital West - Pembroke Pines
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Georgia
- Phoebe Putney Memorial Hospital - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT05554393 shows while recruiting
NCT05554393 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05554393 names 20 study sites across 7 states, led by Idaho, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05554393 about?
NCT05554393 is a clinical study titled "Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)". This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of t...
What is the current status of trial NCT05554393?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2024-09-13. Estimated completion is 2027-12-31.
What conditions does trial NCT05554393 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05554393?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Azacitidine (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05554393?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05554393 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05554393's enrollment target sits among peer trials
153 56th of 306 higher than 250 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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