Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma
Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma
2 other identifiers
interventional
88
1 country
6
Brief Summary
This phase II trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedStudy Start
First participant enrolled
June 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2019
CompletedResults Posted
Study results publicly available
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
ExpectedMay 26, 2026
May 1, 2026
9.6 years
February 17, 2009
January 8, 2020
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response Rate Estimate
To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing \> 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor.
8 weeks
Secondary Outcomes (12)
Acute Hematologic Toxicities
6 months
Acute Infectious Toxicities
6 months
Disease Failure Rate Within Radiation Fields
median 2 year post therapy
Treatment Failure Patterns for Children Treated With Tailored-field Radiation
median 2 years post therapy
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age
median 2 years post therapy
- +7 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALParticipants 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)
Interventions
Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.
The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone
Eligibility Criteria
You may qualify if:
- Histologically confirmed, previously untreated Hodgkin lymphoma.
- Age: Participants must be 21 years of age or younger
- Stage must be classified as one of the following:
- 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
- Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method.
- Signed informed consent
- If re-evaluation of a patient's disease shows intermediate risk features, the patient will be removed from the HOD08.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Packard Children's Hospital, Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital- San Diego
San Diego, California, 92123, United States
Children's Hospital of Illinois at OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Maine Children's Cancer Program (MCCP)
Scarborough, Maine, 04074, United States
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, 02115, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Flerlage JE, Feraco AM, Zhou Y, Zheng Y, Liang J, Lucas JT Jr, Friedmann AM, Weinstein HJ, Yock TI, Shulkin B, Kaste SC, Marks LJ, Ehrhardt MJ, Dixon SB, Howard S, de Alarcon P, Luna-Fineman S, Geddis A, Larsen EC, Marcus K, Billett AL, Donaldson SS, Hudson MM, Metzger ML, Krasin MJ, Link MP. Dose-dense chemotherapy enables elimination of RT for the majority of low-risk pediatric Hodgkin lymphomas: PHC study HOD08. Blood. 2026 Mar 19;147(12):1289-1301. doi: 10.1182/blood.2025029535.
PMID: 41529162DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
During a mechlorethamine shortage cyclophosphamide was administered instead leading to inferior outcome in intermediate and high risk patients. These patients were replaced in this protocol. The study was closed early after our new protocol opened. Enrolled participants may be followed for 10 years after completion of therapy.
Results Point of Contact
- Title
- Matt Ehrhardt, MD, MS
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Matt Ehrhardt, MD, MS
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 19, 2009
Study Start
June 5, 2009
Primary Completion
January 11, 2019
Study Completion (Estimated)
October 1, 2028
Last Updated
May 26, 2026
Results First Posted
February 10, 2020
Record last verified: 2026-05