Chemotherapy for Leukemia and Lymphoma

Recruiting at257 trial locations

Overseen by Anne L Angiolillo

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 partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Research Team

Anne L Angiolillo

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients with newly diagnosed standard-risk acute lymphoblastic leukemia or localized B-lineage lymphoblastic lymphoma. They must not have had previous cancer treatments, except certain steroids or intrathecal cytarabine. Patients need to agree to use effective contraception if applicable and meet all study requirements.

Inclusion Criteria

Your white blood cell count at the start of the study should be less than 50,000 cells per microliter.

All patients and/or their parents or legal guardians must sign a written informed consent

B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932

Exclusion Criteria

I haven't had chemotherapy for my current B-ALL/B-LLy or any cancer before starting the AALL0932 protocol, except for steroids or intrathecal cytarabine.

Lactating females unless they have agreed not to breastfeed their infants

I am not pregnant or have a negative pregnancy test if of childbearing age.

Treatment Details

Interventions

• Cyclophosphamide (Alkylating agents)
• Cytarabine (Anti-metabolites)
• Dexamethasone (Corticosteroid)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Leucovorin Calcium (Anti-metabolites)
• Mercaptopurine (Anti-metabolites)
• Methotrexate (Anti-metabolites)
• Pegaspargase (Enzyme)
• Thioguanine (Anti-metabolites)
• Vincristine Sulfate (Vinca alkaloids)

Trial Overview The trial tests different combinations of chemotherapy drugs on younger patients with specific types of leukemia or lymphoma. It aims to find the best mix and dosage that kills the most cancer cells while monitoring side effects through various stages of treatment.

Participant Groups

Group I: Arm SR DS (12-week cycle maintenance) Experimental Treatment 13 Interventions

See Detailed Description

Group II: Arm LR-M (risk-adapted chemotherapy) Experimental Treatment 8 Interventions

Patients receive consolidation and maintenance therapy. See detailed description.

Group III: Arm LR-C (risk-adapted chemotherapy) Experimental Treatment 12 Interventions

Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.

Group IV: Arm D (risk-adapted chemotherapy) Experimental Treatment 7 Interventions

Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Group V: Arm C (risk-adapted chemotherapy) Experimental Treatment 7 Interventions

Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Group VI: Arm B-LLy (4-week cycle maintenance) Experimental Treatment 13 Interventions

See Detailed Description.

Group VII: Arm B (risk-adapted chemotherapy) Experimental Treatment 7 Interventions

Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Group VIII: Arm A (risk-adapted chemotherapy) Experimental Treatment 7 Interventions

Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

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

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

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

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