Your session is about to expire
← Back to Search
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 belowSelect...
My cancer is early stage with limited spread and no extranodal involvement.
Select...
My Hodgkin lymphoma diagnosis is confirmed and I haven't received any treatment yet.
Select...
I am 21 years old or younger.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,393 Total Patients Enrolled
Jamie Flerlage, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
4 Previous Clinical Trials
481 Total Patients Enrolled
Monika Metzger, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
414 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is early stage with limited spread and no extranodal involvement.My cancer is at an advanced stage or has specific high-risk features.If my disease is reassessed as intermediate risk, I will be taken off the HOD08 trial.My Hodgkin lymphoma diagnosis is confirmed and I haven't received any treatment yet.I am 21 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.