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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Elizabeth Raetz, MD · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-11

Primary Completion

2021-06-30

Completion

2023-09-30

FDA Drug

Yes

Countries

• United States

Study Locations