Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Summary

The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals:

PRIMARY OBJECTIVE:

* Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL.

SECONDARY OBJECTIVES:

* Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.
* Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.
* Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

DRUG

ITMHA

Given intrathecally (IT).

DRUG

Dexamethasone

Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

DRUG

Mitoxantrone

Given IV.

DRUG

Pegaspargase

Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.

DRUG

Asparaginase Erwinia Chrysanthemi

Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).

DRUG

Bortezomib

Given IV.

DRUG

Vorinostat

Taken PO or NG.

DRUG

Cyclophosphamide

Given IV.

DRUG

Mercaptopurine

Given PO or NG.

DRUG

Methotrexate

Given IV, IM or PO.

DRUG

Leucovorin Calcium

Leucovorin rescue PO or IV.

DRUG

Cytarabine

Given IV.

DRUG

Etoposide

Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.

DRUG

Vincristine

Given IV.

Sponsors & Collaborators

• Gateway for Cancer Research

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Tanja Gruber, MD, PhD · Lucile Packard Children's Hospital Stanford University

• Sima Jeha, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

365 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-29

Primary Completion

2022-05-10

Completion

2031-10-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations