Only 92 spots left

~92 spots leftby Nov 2026

Chemotherapy Regimen for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+8 other locations

Melissa Burns, MD - Dana-Farber Cancer ...

Overseen byMelissa A. Burns

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.

Research Team

Melissa A. Burns

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for children and adolescents aged 1 to less than 22 years with a confirmed diagnosis of acute lymphoblastic leukemia (ALL). They must not have had previous cancer treatments, except for short-term corticosteroids or emergent radiation. Participants need parental consent and cannot have chronic steroid use, HIV, uncontrolled illnesses, or be pregnant.

Inclusion Criteria

I have received a dose of cytarabine in my spine before joining this study.

Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L).

I am between 1 and 21 years old.

See 7 more

Exclusion Criteria

Currently receiving any investigational agents.

My leukemia is classified as mixed phenotype or ambiguous lineage.

I do not have any severe illnesses or conditions that could interfere with the study.

See 6 more

Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Cytarabine (Anti-metabolites)
Dasatinib (Tyrosine Kinase Inhibitor)
Dexamethasone (Corticosteroid)
Dexrazoxane (Topoisomerase II inhibitors)
Doxorubicin (Anti-tumor antibiotic)
Erwinia Asparaginase (Enzyme)
Etoposide (Topoisomerase I inhibitors)
Hydrocortisone (Corticosteroid)
Leucovorin Calcium (Antimetabolite)
Mercaptopurine (Antimetabolite)
Methotrexate (Antimetabolite)
Pegaspargase (Enzyme)
Vincristine (Vinca alkaloids)

Trial OverviewThe study tests an updated set of risk factors to determine the intensity of ALL treatment in young patients. It also explores a new dosing method for pegaspargase based on drug levels in the blood. The trial includes various chemotherapy drugs like Doxorubicin and Vincristine over about two years.

Participant Groups

10Treatment groups

Experimental Treatment

Active Control

Group I: Reduced Dose (PK-Adjusted) PegaspargaseExperimental Treatment2 Interventions

Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks beginning at a reduced dose (2000 IU/m2/dose); subsequent doses adjusted based on nadir serum asparaginase activity (NSAA) levels, with goal of maintaining NSAA between 0.4 and 1.0 IU/mL. Closed to Enrollment.

Group II: Initial Very High Risk (Initial VHR)Experimental Treatment15 Interventions

Any of the following are present: IKZF1 deletion, MLL (KMT2A) rearrangement, low hypodiploidy, t(17;19) Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Group III: Initial Low Risk (Initial LR)Experimental Treatment10 Interventions

Meets all the following criteria: B-ALL, Age 1-\<15 years, WBC \< 50,000/microliter, CNS-1 or CNS-2, no BCR-ABL1, no iAMP21, and no VHR characteristics. Treated with Induction IA (vincristine, dexamethasone, pegaspargase), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Group IV: Initial High Risk (Initial HR)Experimental Treatment12 Interventions

Meets at least one of the following criteria: Age \>=15 years, WBC \>=50,000/microliter, CNS-3, T-ALL, iAMP21, BCR-ABL1 And: No VHR characteristics Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA.

Group V: Final Very High Risk (Final VHR)Experimental Treatment15 Interventions

Initial VHR or any patient with high MRD (\>=0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: Consolidation IB/B-ALL (High-dose methotrexate + leucovorin, cyclophosphamide, etoposide, IT chemotherapy); Consolidation IB/T-ALL (nelararbine, cyclophosphamide, etoposide); Consolidation IC (High-dose cytarabine, etoposide, dexamethasone, pegaspargase \[by direct assignment\], IT chemotherapy); CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). Dasatinib administered daily during all phases to pts with ABL1-class fusions. All treatment completed 24 months from date of complete remission.

Group VI: Final Low Risk (Final LR)Experimental Treatment8 Interventions

Initial Low Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, methotrexate, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Group VII: Final Intermediate Risk (Final IR)Experimental Treatment10 Interventions

Initial High Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Group VIII: Final High Risk (Final HR)Experimental Treatment10 Interventions

Initial Low Risk or Initial High Risk with High MRD (\>=0.0001) at first time point (Day 32) but low MRD (\<0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission.

Group IX: Direct AssignmentExperimental Treatment2 Interventions

All VHR patients, and any Final LR, IR, HR patients who decline randomization: Assigned to receive standard dosing of pegaspargase (15 doses of pegaspargase every 2-weeks at standard fixed-dose; 2500 IU/m2/dose).

Group X: Fixed Dose PegaspargaseActive Control2 Interventions

Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks at standard fixed-dose (2500 IU/m2/dose).

Cyclophosphamide is already approved in Canada, Japan for the following indications: