Imatinib + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting at 249 trial locations

Overseen By Mignon L. Loh

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must be taking: Imatinib

Must not be taking: Dasatinib, other TKIs

Disqualifiers: CML, Down syndrome, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

475 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction IA Part 1

Patients receive induction IA according to standard of care on days 1-14

2 weeks

Induction IA Part 2

Patients receive imatinib mesylate and other chemotherapy agents

2.5 weeks

Induction IB

Patients receive imatinib mesylate and a combination of chemotherapy agents

5 weeks

Post-Induction Therapy

Patients receive various consolidation and intensification therapies based on risk classification

Varies by arm

Maintenance

Patients receive imatinib mesylate and other maintenance chemotherapy agents

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation
• Calaspargase Pegol
• Cyclophosphamide
• Daunorubicin Hydrochloride
• Dexamethasone
• Doxorubicin
• Etoposide
• Imatinib Mesylate
• Mercaptopurine
• Methotrexate
• Methylprednisolone
• Pegaspargase
• Prednisolone
• Therapeutic Hydrocortisone
• Thioguanine
• Vincristine Sulfate

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 United States, Canada for the following indications:

Approved in United States as Asparlas for:

• Acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged one month to 21 years

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+

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+