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Anti-tumor antibiotic

Chemotherapy + Radiation for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Jamie Flerlage, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Stage must be classified as Ann Arbor stage IA or IIA with: Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR), < 3 nodal regions involved on the same side of the diaphragm, No 'E' lesion

Histologically confirmed, previously untreated Hodgkin lymphoma

Must not have

Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with 'E' lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median 2 year post therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of chemotherapy drugs with or without radiation therapy to see how well it treats young patients with a low-risk form of Hodgkin lymphoma.

Who is the study for?

This trial is for young patients, 21 years or younger, with a type of cancer called favorable-risk Hodgkin lymphoma. They should not have been treated before and must have specific early stages of the disease without extensive spread. Girls after puberty need a negative pregnancy test and all participants able to have children must use birth control.

What is being tested?

The study is testing how well a mix of chemotherapy drugs works compared to the same chemo plus radiation therapy in these young patients. The goal is to see if adding radiation helps more when some cancer remains after chemo, while trying to preserve healthy body parts.

What are the potential side effects?

Chemotherapy can cause side effects like nausea, hair loss, fatigue, increased risk of infections due to low blood cell counts, and potential damage to organs such as the heart or lungs. Radiation may lead to skin irritation at the treatment site and possible long-term risks like secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is early stage with limited spread and no extranodal involvement.

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My Hodgkin lymphoma diagnosis is confirmed and I haven't received any treatment yet.

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I am 21 years old or younger.

Exclusion Criteria

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

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My cancer is at an advanced stage or has specific high-risk features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median 2 year post therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median 2 year post therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and median 2 year post therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete Response Rate Estimate

Secondary study objectives

Acute Hematologic Toxicities

Acute Infectious Toxicities

Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Participants receive Stanford V Chemotherapy with or without radiation therapy. Patients receive doxorubicin hydrochloride IV and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day of weeks 1-8. Beginning 2-3 weeks after completion of chemotherapy, patients not achieving complete response undergo radiation therapy to individual nodal sites (tailored fields)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met