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NCT03576547 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03576547: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03576547 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03576547, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I/II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia or chronic myelogenous leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as venetoclax and dexamethasone, 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. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, ponatinib, and dexamethasone may work better in treating participants with acute lymphoblastic leukemia or chronic myelogenous leukemia.
Primary Outcome
MTD is defined as the highest dose level where a dose limiting toxicity (DLT) occurs within at most one out of six patients treated. The MTD is defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria. Patients will be continued to be followed for one year for evidence of late toxicity.
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
- BIOLOGICAL Rituximab
- DRUG Ponatinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2024-06-19 |
| Phase | Phase 1 |
Why NCT03576547 stopped before completion
NCT03576547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Venetoclax is the first listed.
NCT03576547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03576547 about?
NCT03576547 is a clinical study titled "Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia". This phase I/II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia or chronic myelogenous leukemia that has come back or do...
What is the current status of trial NCT03576547?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-06-26. Estimated completion is 2024-06-19.
What interventions are being tested in trial NCT03576547?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Rituximab (BIOLOGICAL), Ponatinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03576547?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03576547's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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