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NCT03515200 · ClinicalTrials.gov registry record · Phase 1
Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03515200: Clinical Trial Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT03515200 is a Phase 1 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515200, a Phase 1 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the laboratory and in animal studies. Palbociclib will be added to other chemotherapy drugs, such as dexamethasone, that are known to be effective in treating childhood ALL. This study will be done in two parts: Part 1: Dose Escalation and Part 2: Dose Expansion. The goal of Part 1 of the study is to find the highest tolerable combination of palbociclib and chemotherapy that the investigators can give to patients with leukemia. Once those doses are determined, the investigators will enroll patients on Part 2: Dose Expansion. This phase will enroll additional patients that receive the highest tolerated dose of palbociclib as determined in part 1, in order to better understand the side effects and how effective this treatment approach is. With this research study, the investigators hope to meet the following goals: * To find the highest tolerable dose of palbociclib in combination with chemotherapy that can be given without causing severe side effects; * To learn what kind of side effects palbociclib in combination with chemotherapy may have; and * To learn more about the biology effects of palbociclib on the cells in the participant's body. Up to 40 children, adolescents and young adults will participate in both parts of this study at St. Jude only.
Primary Outcome
Determine a tolerable combination of palbociclib plus chemotherapy in pediatric patients with relapsed or refractory ALL.
Interventions
- DRUG Dexamethasone
- DRUG Dasatinib
- DRUG Bortezomib
- DRUG Intrathecal Triple Therapy
- DRUG Palbociclib Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-04-20 |
| Est. Completion | 2020-07-29 |
| Phase | Phase 1 |
Why NCT03515200 stopped before completion
NCT03515200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03515200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03515200 about?
NCT03515200 is a clinical study titled "Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia". Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the laboratory and in animal studie...
What is the current status of trial NCT03515200?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-04-20. Estimated completion is 2020-07-29.
What interventions are being tested in trial NCT03515200?
The interventions under investigation include: Dexamethasone (DRUG), Dasatinib (DRUG), Bortezomib (DRUG), Intrathecal Triple Therapy (DRUG), Palbociclib Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03515200?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03515200's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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