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NCT04501614 · ClinicalTrials.gov registry record · Phase 1
A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT04501614: Clinical Trial Phase 1 study, sponsored by Takeda.
NCT04501614 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04501614, a Phase 1 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment. The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission. Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets or who are receiving less than a 10 milligrams (mg) dose, a capsule with small ponatinib minitablets inside will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.
Primary Outcome
The RP2D is the maximum tolerated dose (MTD) or less.
Interventions
- DRUG Ponatinib
- DRUG Chemotherapy Agents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2024-07-19 |
| Phase | Phase 1 |
Why NCT04501614 stopped before completion
NCT04501614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Ponatinib is the first listed.
NCT04501614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04501614 about?
NCT04501614 is a clinical study titled "A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia". This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment...
What is the current status of trial NCT04501614?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-02-24. Estimated completion is 2024-07-19.
What interventions are being tested in trial NCT04501614?
The interventions under investigation include: Ponatinib (DRUG), Chemotherapy Agents (DRUG).
Who is sponsoring clinical trial NCT04501614?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04501614's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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