Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04655755 · ClinicalTrials.gov registry record · Phase 1
Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
A Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT04655755: Active Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04655755 is a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 52 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655755, a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, 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.
Primary Outcome
The overall incidence and severity of all reported adverse events using Common Toxicity Criteria version 5.0.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine and Cedazuridine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2026-07-20 |
| Phase | Phase 1 |
What the registry record for NCT04655755 still lists
NCT04655755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT04655755 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04655755 about?
NCT04655755 is a clinical study titled "Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia". This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy d...
What is the current status of trial NCT04655755?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-01-19. Estimated completion is 2026-07-20.
What conditions does trial NCT04655755 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT04655755?
The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT04655755?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04655755 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04655755's enrollment target sits among peer trials
52 65th of 134 higher than 69 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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
-
A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
RECRUITING · Phase 1
-
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI