Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Treatment using Palbociclib and Chemotherapy – Phase I

AIVN18P1: Study of Palbociclib, a CDK 4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Protocol Description

Through this study by the Pediatric Early Phase Clinical Trial Network of Children’s Oncology Group, researchers will determine the effects of and how the body processes palbociclib, administered in combination with re-induction chemotherapy in pediatric patients with relapsed B- or T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma (ALL or LL). Additionally, researchers will determine if this course of combination treatment will increase the percentage of patients who achieve remission after one month of therapy. Palbociclib has shown promising activity against leukemia in laboratory experiments and has been approved by the U.S. Food and Drug Administration for the treatment of other cancers in adults.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling pediatric patients who have been diagnosed with ALL or LL that has come back after treatment or has not responded to treatment.
Males and Females: Ages 12 months to 31 years


Participants in this study will take palbociclib once daily for 21 days. Additional medications and chemotherapy will be required on days 1, 4, 5, 11, 18, 25, 31 and 32. Most participants receiving the study drug will be treated in the hospital, but some may be able to take the medication at home. Blood and bone marrow testing will be required.
Visits: Requires hospitalization
Duration: About 32 days

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AIVN18P1)

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact:
Melissa Repine, Clinical Research Coordinator