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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: Active Phase 1 study of Myelodysplastic Syndrome and Recurrent Myelodysplastic Syndrome, sponsored by Thomas Jefferson University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Bayesian optimal interval (BOIN) design will be employed to find the MTD. The BOIN design is implemented in a simple way. It is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model based designs.
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 |
What the registry record for NCT05564650 still lists
NCT05564650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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
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Where NCT05564650's enrollment target sits among peer trials
6 134th of 134 higher than 1 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.
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