Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

Summary

Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the laboratory and in animal studies. Palbociclib will be added to other chemotherapy drugs, such as dexamethasone, that are known to be effective in treating childhood ALL.

This study will be done in two parts: Part 1: Dose Escalation and Part 2: Dose Expansion. The goal of Part 1 of the study is to find the highest tolerable combination of palbociclib and chemotherapy that the investigators can give to patients with leukemia. Once those doses are determined, the investigators will enroll patients on Part 2: Dose Expansion. This phase will enroll additional patients that receive the highest tolerated dose of palbociclib as determined in part 1, in order to better understand the side effects and how effective this treatment approach is.

With this research study, the investigators hope to meet the following goals:

* To find the highest tolerable dose of palbociclib in combination with chemotherapy that can be given without causing severe side effects;
* To learn what kind of side effects palbociclib in combination with chemotherapy may have; and
* To learn more about the biology effects of palbociclib on the cells in the participant's body.

Up to 40 children, adolescents and young adults will participate in both parts of this study at St. Jude only.

Conditions

• Acute Lymphoblastic Leukemia, in Relapse
• Acute Lymphoblastic Leukemia With Failed Remission

Interventions

DRUG

Palbociclib Oral Capsule

Given orally or nasogastrically (NG).

DRUG

Intrathecal Triple Therapy

Given intrathecally (IT).

DRUG

Dexamethasone

Given orally, nasogastrically (NG) or intravenously (IV).

DRUG

Bortezomib

Given intravenously (IV) or subcutaneously (SC).

DRUG

Dasatinib

Given orally or nasogastrically (NG).

DRUG

Doxorubicin

Given intravenously (IV).

DRUG

Ruxolitinib

Given orally or nasogastrically (NG).

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Tanja A. Gruber, MD, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-20

Primary Completion

2020-07-29

Completion

2020-07-29

FDA Drug

Yes

Countries

• United States

Study Locations