Clinical trialNCT03792256CompletedPhase 1Interventional

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

SponsorChildren's Oncology GroupEnrollment12Acute LeukemiaLeukemia, LymphocyticLymphoblastic LymphomaRecurrent DiseaseT-cell LeukemiaT-cell Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Elizabeth Raetz, MD
Children's Oncology Group
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Children'S Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
C S Mott Children'S Hospital
Ann Arbor, Michigan, United States
University of Minnesota/masonic Cancer Center
Minneapolis, Minnesota, United States
Laura and Isaac Perlmutter Cancer Center at Nyu Langone
New York, New York, United States
Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center
New York, New York, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Saint Jude Children'S Research Hospital
Memphis, Tennessee, United States
Primary Children'S Hospital
Salt Lake City, Utah, United States
Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cytarabine →Doxorubicin →Hydrocortisone / lactate →Methotrexate →Palbociclib →Pegaspargase →Prednisolone →Prednisone →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Apr 2019
Primary completion: 30 Jun 2021
Completion: 30 Sept 2023
Last update posted: 21 Mar 2025
Registered enrollment: 12
Registry id: NCT03792256

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.