Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Conditions

• Acute Lymphoblastic Leukemia
• B Acute Lymphoblastic Leukemia
• Mixed Phenotype Acute Leukemia
• T Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

DRUG

Calaspargase Pegol

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV, SC, or IT

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Dexrazoxane Hydrochloride

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC or IV

DRUG

Ifosfamide

Given IV

DRUG

Imatinib Mesylate

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given PO or IV

DRUG

Levoleucovorin

Given PO or IV

DRUG

Mercaptopurine

Given PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT

DRUG

Methylprednisolone

Given IV

DRUG

Pegaspargase

Given IV

DRUG

Prednisolone

Given PO

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• EsPhALL

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Lewis B Silverman · Children's Oncology Group

• Prof. Andrea Biondi · EsPhALL Network/ BFM Study Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-08

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• Canada
• Chile
• Czechia
• Finland
• France
• Germany
• Hong Kong
• Israel
• Italy
• Netherlands
• New Zealand
• Puerto Rico
• Saudi Arabia
• Sweden
• Switzerland

Study Locations