Chemotherapy + Radiation for Hodgkin's Lymphoma

Not currently recruiting at 5 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Intermediate/high risk disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combination chemotherapy, with or without radiation therapy, in treating young patients with favorable-risk Hodgkin lymphoma, a cancer affecting the lymphatic system. The chemotherapy drugs work together to stop cancer cells from growing or dividing, potentially leading to better outcomes. Radiation therapy may be added for patients who still have cancer after chemotherapy to further target and kill cancer cells. The trial seeks participants diagnosed with Hodgkin lymphoma for the first time, with a limited number of affected areas. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Stanford V chemotherapy treatment, with or without radiation, is generally well-tolerated for treating Hodgkin lymphoma. Since 2002, this combination has achieved high cure rates. Although some patients have experienced side effects such as flu-like symptoms and lung problems, these remain uncommon.

When combined with chemotherapy, radiation therapy is also considered safe and effective. Modern radiation techniques aim to minimize side effects while effectively treating Hodgkin lymphoma. These findings suggest that the treatments in this trial are safe based on past use and research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for Hodgkin's Lymphoma because it combines chemotherapy with a tailored approach to radiation therapy. Unlike standard treatments that may use a blanket approach to radiation, this method targets specific nodal sites, potentially reducing side effects and focusing treatment more precisely where it's needed. Additionally, the Stanford V Chemotherapy regimen includes a unique combination of drugs like mechlorethamine hydrochloride and bleomycin, which are administered in a specific schedule to maximize effectiveness. This tailored and comprehensive approach aims to enhance the treatment's success rate while minimizing harm to healthy tissues.

What evidence suggests that this trial's treatments could be effective for Hodgkin's Lymphoma?

Research has shown that the Stanford V chemotherapy plan is highly effective for treating Hodgkin's lymphoma. In studies with patients in the early stages of the disease, about 94% did not experience cancer progression even after more than ten years, indicating strong long-term success. In this trial, participants will receive Stanford V chemotherapy, and those not achieving a complete response may also undergo radiation therapy. Radiation therapy can increase survival chances for patients who still have cancer after chemotherapy. It is very effective at controlling cancer in the specific area where it is applied. Together, these treatments offer a robust approach to managing Hodgkin's lymphoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Matt Ehrhardt, MD, MS

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method

If my disease is reassessed as intermediate risk, I will be taken off the HOD08 trial.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive Stanford V chemotherapy regimen over 8 weeks

8 weeks

Weekly visits for IV administration

Radiation

Patients not achieving complete response undergo radiation therapy to individual nodal sites

2-3 weeks after chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

median 2 years post therapy

What Are the Treatments Tested in This Trial?

Interventions

• Bleomycin
• Doxorubicin Hydrochloride
• Etoposide
• Mechlorethamine Hydrochloride
• Prednisone
• Radiation Therapy
• Vinblastine
• Vincristine Sulfate

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 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)

Bleomycin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bleomycin for:

• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Testicular cancer
• Ovarian cancer
• Malignant pleural effusions

Approved in United States as Bleomycin for:

• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Testicular cancer
• Ovarian cancer
• Malignant pleural effusions

Approved in Canada as Bleomycin for:

• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Testicular cancer
• Ovarian cancer
• Malignant pleural effusions

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

In a phase III trial involving 794 patients, the study found that both ABVD and Stanford V chemotherapy regimens had similar efficacy in treating stage I or II bulky mediastinal Hodgkin lymphoma, with overall response rates of 83% and 88%, respectively.

At a median follow-up of 6.5 years, there were no significant differences in 5-year failure-free survival (85% for ABVD vs. 79% for Stanford V) or overall survival (96% for ABVD vs. 92% for Stanford V), indicating that both treatment options are viable for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase III Trial Comparing ABVD Plus Radiotherapy With the Stanford V Regimen in Patients With Stages I or II Locally Extensive, Bulky Mediastinal Hodgkin Lymphoma: A Subset Analysis of the North American Intergroup E2496 Trial. Advani, RH., Hong, F., Fisher, RI., et al.[2021]

The British National Lymphoma Investigation (BNLI) has shown that MOPP chemotherapy is more effective than MOP, and that LOPP is equally effective as MOPP but with less acute toxicity, highlighting the importance of optimizing chemotherapy regimens for Hodgkin's disease.

High-dose BEAM chemotherapy followed by autologous bone marrow transplantation is superior for treating poor-risk relapsed and refractory Hodgkin's disease, indicating a promising approach for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials in advanced Hodgkin's disease: more than 30 years experience of the British National Lymphoma Investigation. Zekri, JM., Mouncey, P., Hancock, BW.[2019]

A systematic review of 62 randomized controlled trials found that the five-year overall survival rates for ABVD and BEACOPP regimens in advanced-stage Hodgkin lymphoma were 60-97% and 84-99%, respectively, indicating high efficacy for both treatments.

The new treatment A+AVD showed improved efficacy compared to ABVD while maintaining an acceptable tolerability profile, suggesting it may be a more manageable option for patients with advanced-stage Hodgkin lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of front-line treatments for advanced Hodgkin lymphoma: a systematic literature review. Dalal, M., Gupta, J., Price, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854861/

Long-Term Results of IFRT vs. ISRT in Infradiaphragmal ... The survival rates in our study (68% at 5 years) are consistent with lymphoma outcomes. According to the National Cancer Institute data from ...

2. ar.iiarjournals.org ar.iiarjournals.org/content/37/6/3035

Effect of Radiation Therapy on Survival in Hodgkin's ... Across all stages, our results showed an improved overall survival for patients treated with radiation therapy when compared to those who were not treated with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0037196324000702

Contemporary radiation therapy use in Hodgkin lymphoma Radiation therapy is considered the most effective single modality for achieving local control in HL. With modern radiation fields and dosages, the occurrence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4607569/

Image-guided radiation therapy in lymphoma management At a median follow-up of 54 months for 3D-CRT and 24 months for IGRT-IMRT patients, there were no differences in relapse-free survival, 98.7% vs. 100%. However, ...

5. redjournal.org redjournal.org/article/S0360-3016(24)00514-5/fulltext

Involved-site Radiation Therapy is Equally Effective and ... Kaplan-Meier estimates of 4-year progression-free survival were 96.8% (95% CI, 91.6%-98.8%) in the IFRT group and 95.4% (95% CI, 89.9%-97.9%; HR ...

6. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00226-9/fulltext

Proton beam therapy for mediastinal Hodgkin lymphoma Proton beam therapy using pencil beam scanning is a safe and effective technique in terms of toxicity and local control, even when irradiating mediastinal ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23790512/

Modern radiation therapy for Hodgkin lymphoma: field and ... Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the international lymphoma radiation oncology group (ILROG).

8. jnm.snmjournals.org jnm.snmjournals.org/content/44/3/465

Radiation Dosimetry Results and Safety Correlations from 90Y ... Radiation Dosimetry Results and Safety Correlations from 90Y-Ibritumomab Tiuxetan Radioimmunotherapy for Relapsed or Refractory Non-Hodgkin's ...