475 Participants Needed

Imatinib + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting at 249 trial locations
ML
Overseen ByMignon L. Loh
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Children's Oncology Group
Must be taking: Imatinib
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

PA

Prof. Andrea Biondi

Principal Investigator

EsPhALL Network/ BFM Study Group

LB

Lewis B Silverman

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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.
See 14 more

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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)Experimental Treatment24 Interventions
Group II: Arm B (imatinib mesylate, COG/BFM chemotherapy)Experimental Treatment18 Interventions
Group III: Arm A (imatinib mesylate, EsPhALL chemotherapy)Experimental Treatment23 Interventions

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

🇺🇸
Approved in United States as Asparlas for:
🇨🇦
Approved in Canada as Asparlas for:

Find a Clinic Near You

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+
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