CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Palbociclib +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03792256
NCT03792256Phase 1Completed
CompareCT.gov

A Phase 1 Study of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, in Combination With Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Children's Oncology Group·interventional·Posted Jan 3, 2019·Updated Mar 21, 2025

In Brief

A Phase 1 clinical trial evaluating Palbociclib, Cytarabine, and 7 other interventions for Leukemia, Lymphocytic and 5 related conditions. Completed, enrolled 12 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphocytic, Lymphoblastic Lymphoma, T-cell Lymphoma, T-cell Leukemia, Recurrent Disease, Acute Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 3, 2019
Enrollment StartApr 11, 2019
Primary CompletionJun 30, 2021
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.5 years ago

Interventions

Palbociclibdrug

Given PO (or via NG- tube)

Cytarabinedrug

Given intrathecally (IT)

Methotrexatedrug

Given intrathecally (IT)

Hydrocortisonedrug

Given IT

Doxorubicindrug

Given intravenously (IV)

Prednisolonedrug

Either prednisone or prednisolone is given PO

Vincristinedrug

Given IV

Pegaspargasedrug

Given IV

Hydrocortisonedrug

Given intrathecally (IT)

Prednisonedrug

Either prednisone or prednisolone is given PO