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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03515200
The ClinicalTrials.gov registry entry for NCT03515200 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03515200 reports 0 study locations.
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.
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