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Alkylating agents

Chemotherapy for Leukemia and Lymphoma

Phase 3

Waitlist Available

Led By Anne L Angiolillo

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible

Be younger than 65 years old

Must not have

Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932, except for steroid pretreatment or the administration of intrathecal cytarabine

Female patients of childbearing potential unless a negative pregnancy test result has been obtained

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.7 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing different combinations of chemotherapy drugs to treat patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy drugs like Dexamethasone, Mercaptopurine, and others may cause nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, mouth sores, and potential damage to organs such as the heart or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with a specific type of leukemia and may have Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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

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I am currently pregnant.

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My leukemia has spread to my brain or spinal cord.

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My leukemia has spread to my brain/spinal cord or testicles.

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My leukemia involves a specific range of immature blood cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care

DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization

DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens

+4 more

Secondary study objectives

Tumor Burden

Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical

Tumor Burden

+39 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Arm SR DS (12-week cycle maintenance)Experimental Treatment13 Interventions

See Detailed Description

Group II: Arm LR-M (risk-adapted chemotherapy)Experimental Treatment8 Interventions

Patients receive consolidation and maintenance therapy. See detailed description.

Group III: Arm LR-C (risk-adapted chemotherapy)Experimental Treatment12 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 Treatment7 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 Treatment7 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 Treatment13 Interventions

See Detailed Description.

Group VII: Arm B (risk-adapted chemotherapy)Experimental Treatment7 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 Treatment7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mercaptopurine

2012

Completed Phase 4

~12550

Dexamethasone

2007

Completed Phase 4

~2650