Imatinib + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting at249 trial locations

Overseen by Lewis B Silverman

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests how well the drug imatinib works with different chemotherapy treatments for patients with specific types of leukemia. It aims to find out if a less intense chemotherapy regimen can be as effective as a stronger one but with fewer side effects. The study focuses on patients with certain types of acute lymphoblastic leukemia.

Research Team

Prof. Andrea Biondi

Principal Investigator

EsPhALL Network/ BFM Study Group

Lewis B Silverman

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients up to 21 years old with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) or similar ABL-class fusion positive ALL. They must have started standard induction therapy but not received more than 14 days of it, and their organ functions should meet specific criteria. Excluded are those with chronic myelogenous leukemia, previous cancer treated with cytotoxic chemotherapy, uncontrolled infections or illnesses requiring intensive support, Down syndrome, pregnancy or breastfeeding women, and those unwilling to use contraception.

Inclusion Criteria

I started treatment with specific drugs for my Ph+ condition.

For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled

My cancer has a confirmed ABL-class gene fusion.

Exclusion Criteria

Down syndrome

Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol

I have a history of specific heart rhythm problems.

Treatment Details

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
• Calaspargase Pegol (Chemotherapy)
• Cyclophosphamide (Chemotherapy)
• Daunorubicin Hydrochloride (Chemotherapy)
• Dexamethasone (Corticosteroid)
• Doxorubicin (Topoisomerase II Inhibitor)
• Etoposide (Topoisomerase II Inhibitor)
• Imatinib Mesylate (Tyrosine Kinase Inhibitor)
• Mercaptopurine (Chemotherapy)
• Methotrexate (Chemotherapy)
• Methylprednisolone (Corticosteroid)
• Pegaspargase (Enzyme)
• Prednisolone (Corticosteroid)
• Therapeutic Hydrocortisone (Chemotherapy)
• Thioguanine (Chemotherapy)
• Vincristine Sulfate (Chemotherapy)

Trial Overview The study tests imatinib mesylate combined with two different chemotherapy regimens in treating new cases of Philadelphia chromosome positive ALL. It aims to determine if a less intense chemo regimen can be as effective as a stronger one when paired with imatinib but cause fewer side effects. The effectiveness of this combination is also being tested on another group with ABL-class fusion positive ALL.

Participant Groups

Group I: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT) Experimental Treatment 24 Interventions

See Detailed Description

Group II: Arm B (imatinib mesylate, COG/BFM chemotherapy) Experimental Treatment 18 Interventions

See Detailed Description.

Group III: Arm A (imatinib mesylate, EsPhALL chemotherapy) Experimental Treatment 23 Interventions

See Detailed Description

Calaspargase Pegol is already approved in Canada for the following indications:

Approved in Canada as Asparlas for:

• Acute lymphoblastic leukemia (ALL)

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s

EsPhALL network I-BFM Study Group

Collaborator

Trials

1

Recruited

480+

EsPhALL Network/ BFM Study Group

Collaborator

Trials

1

Recruited

480+

EsPhALL

Collaborator

Trials

2

Recruited

580+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School