NCT03792256

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 12 Months – 31 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of palbociclib administered in combination with re-induction chemotherapy in pediatric patients with relapsed B- or T-lineage ALL/LL. II. To define and describe the toxicities of palbociclib administered on this schedule. III. To characterize the pharmacokinetics of palbociclib in pediatric patients with relapsed B- or T-lineage ALL/LL. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of palbociclib in combination with chemotherapy for children with relapsed ALL/LL within the confines of a Phase 1 study. II. To assess the biologic activity of palbociclib in this patient population. OUTLINE: Patients receive Palbociclib PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) on Day 1, Doxorubicin IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone PO on days 4-31; Vincristine IV push or mini-bag per institutional policy on Days 4, 11, 18, and 25; and Pegaspargase IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) on days 4, 11,18, and 25. If CNS1 or 2 disease status, patients receive Methotrexate (IT MTX) on Days 18 and 32. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity.

Conditions

• Leukemia, Lymphocytic
• Lymphoblastic Lymphoma
• T-cell Lymphoma
• T-cell Leukemia
• Recurrent Disease
• Acute Leukemia

Interventions

Type	Name	Description
DRUG	Palbociclib	Given PO (or via NG- tube)
DRUG	Cytarabine	Given intrathecally (IT)
DRUG	Methotrexate	Given intrathecally (IT)
DRUG	Hydrocortisone	Given IT
DRUG	Doxorubicin	Given intravenously (IV)
DRUG	Prednisolone	Either prednisone or prednisolone is given PO
DRUG	Vincristine	Given IV
DRUG	Pegaspargase	Given IV
DRUG	Hydrocortisone	Given intrathecally (IT)
DRUG	Prednisone	Either prednisone or prednisolone is given PO

Timeline

• Start date: 2019-04-11
• Primary completion: 2021-06-30
• Completion: 2023-09-30
• First posted: 2019-01-03
• Last updated: 2025-03-21
• Results posted: 2024-08-16

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study