Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05564650 · ClinicalTrials.gov registry record · Phase 1
Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
A Phase 1 study of Myelodysplastic Syndrome and Recurrent Myelodysplastic Syndrome, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05564650 is a Phase 1 study of Myelodysplastic Syndrome and Recurrent Myelodysplastic Syndrome that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 6 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05564650, a Phase 1 study of Myelodysplastic Syndrome and Recurrent Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial tests the safety, side effects, and best dose of navitoclax in combination with venetoclax and decitabine in treating patients with higher risk myelodysplastic syndrome (MDS) that has come back after initial treatment or was not responsive to initial treatment. This study will also look at the effectiveness of the treatment combination and patient's quality of life while on these medications. Navitoclax is an oral drug that works as an inhibitor of the BCL-2 family of proteins, which are often overly expressed in a wide variety of cancers and are linked to tumor drug resistance. This drug blocks some of the enzymes that keep cancer cells from dying. Venetoclax is an oral drug that works as an inhibitor of BCL-2 proteins that works very similarly to navitoclax by blocking the action of a certain proteins in the body that helps cancer cells survive which helps to kill cancer cells. Decitabine is an intravenous drug. It is a hypomethylating agent which means it interferes with deoxyribonucleic acid (DNA) methylation. DNA methylation is a major factor that regulates gene expression in cells, and an increase in DNA methylation can block the genes that regulate cell division and growth. When these genes are blocked the overall result allows or promotes cancer as there is no control over cell growth. Decitabine stops cells from making DNA and may kill cancer cells. Participation in this trial may improve the understanding of both chemotherapy response in MDS and mechanisms of resistance to current therapies.
Conditions Studied
Interventions
- DRUG Venetoclax
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine
- BIOLOGICAL Navitoclax
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2026-05-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05564650
The ClinicalTrials.gov registry entry for NCT05564650 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (97% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT05564650 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05564650 about?
NCT05564650 is a clinical study titled "Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome". This trial tests the safety, side effects, and best dose of navitoclax in combination with venetoclax and decitabine in treating patients with higher risk myelodysplastic syndrome (MDS) that has come back after initial treatment or was not responsive to initial treatment. This study will also look a...
What is the current status of trial NCT05564650?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-01-12. Estimated completion is 2026-05-08.
What conditions does trial NCT05564650 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome.
What interventions are being tested in trial NCT05564650?
The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine (DRUG), Navitoclax (BIOLOGICAL).
Who is sponsoring clinical trial NCT05564650?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564650 being conducted?
This trial has 1 study location across Pennsylvania. 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.
-
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
Explore more on PlainTrial
Myelodysplastic Syndrome
All registered trials for this condition
Recurrent Myelodysplastic Syndrome
All registered trials for this condition
Pennsylvania
All trials with a study site in Pennsylvania
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
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.