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NCT03792256 · ClinicalTrials.gov registry record · Phase 1
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03792256: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT03792256 is a Phase 1 study that has completed, run by Children's Oncology Group. 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
NCT03792256, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.
Primary Outcome
The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to Palbociclib by study part and dose level.
Interventions
- DRUG Doxorubicin
- DRUG Palbociclib
- DRUG Cytarabine
- DRUG Methotrexate
- DRUG Hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 1 |
What the finished NCT03792256 record still lists
NCT03792256 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 Doxorubicin is the first listed.
NCT03792256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03792256 about?
NCT03792256 is a clinical study titled "Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)". AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are mo...
What is the current status of trial NCT03792256?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-04-11. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03792256?
The interventions under investigation include: Doxorubicin (DRUG), Palbociclib (DRUG), Cytarabine (DRUG), Methotrexate (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT03792256?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03792256'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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