250 Participants Needed

Chemotherapy + Radiotherapy for Hodgkin's Lymphoma

Recruiting at 7 trial locations
JF
MJ
Overseen ByMatthew J. Ehrhardt
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the chemotherapy and radiotherapy treatment for Hodgkin's Lymphoma?

Research shows that the BEABOVP regimen, which includes bendamustine, is being used as a frontline treatment for pediatric Hodgkin lymphoma with promising results. Additionally, the T(R)EC regimen, which includes bendamustine, demonstrated high response rates in patients with relapsed or refractory Hodgkin lymphoma, indicating its potential effectiveness.12345

Is the combination of chemotherapy and radiotherapy generally safe for treating Hodgkin's Lymphoma?

The safety of chemotherapy drugs like doxorubicin, bleomycin, vinblastine, and dacarbazine, used in Hodgkin's Lymphoma treatment, has been studied, showing that they are generally well-tolerated with mild and temporary side effects. However, nausea and vomiting are common side effects, and antiemetic (anti-nausea) medications are often used to manage these symptoms effectively.678910

What makes the chemotherapy and radiotherapy treatment for Hodgkin's Lymphoma unique?

This treatment combines multiple drugs, including Bendamustine, Brentuximab Vedotin, and others, which are not typically used together in standard regimens like ABVD or Stanford V. The inclusion of these drugs may offer a novel approach by potentially enhancing effectiveness or reducing toxicity compared to traditional treatments.1112131415

What is the purpose of this trial?

This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.

Research Team

ME

Matthew J. Ehrhardt

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children and young adults up to age 25 with untreated CD30+ classical Hodgkin lymphoma. Eligible participants have various stages of the disease, adequate organ function, and no prior therapy for Hodgkin's except limited emergency treatments. They must be able to perform normal activities without significant breathing issues.

Inclusion Criteria

My cancer is in an early stage without significant spread.
I was diagnosed before my 22nd birthday.
I agree to use effective birth control during the study.
See 13 more

Exclusion Criteria

CD30 negative HL
I have a severe nerve condition that affects my ability to assess nerve damage.
I am unable or unwilling to give my consent for participation.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Low-risk and intermediate-risk patients receive BEABOVP chemotherapy; high-risk patients receive AEPA and CAPDac chemotherapy

8 months

Radiotherapy

Residual node radiotherapy is given at the end of all chemotherapy to involved nodes that do not have an adequate response after 2 cycles of therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Bendamustine
  • Bleomycin
  • Brentuximab Vedotin
  • Cyclophosphamide
  • Doxorubicin
  • DTIC
  • Etoposide
  • Filgrastim
  • Prednisone
  • Radiotherapy
  • Vinblastine
  • Vincristine
Trial Overview The study tests different chemotherapy combinations based on risk levels: low/intermediate-risk patients receive BEABOVP regimen; high-risk patients get AEPA and CAPDac regimens. Some may also need radiotherapy if their nodes don't respond well after two cycles of chemo.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Low-RiskExperimental Treatment10 Interventions
Participants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Group II: Intermediate-RiskExperimental Treatment10 Interventions
Participants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Group III: High-RiskExperimental Treatment9 Interventions
Participants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.

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

🇺🇸
Approved in United States as Treanda for:
  • Chronic lymphocytic leukemia
  • Non-Hodgkin lymphoma
🇪🇺
Approved in European Union as Ribomustin for:
  • Chronic lymphocytic leukemia
  • Non-Hodgkin lymphoma
  • Multiple myeloma
🇨🇦
Approved in Canada as Levact for:
  • Chronic lymphocytic leukemia
  • Non-Hodgkin lymphoma
🇯🇵
Approved in Japan as Bendamustine hydrochloride for:
  • Chronic lymphocytic leukemia
  • Non-Hodgkin lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Seagen Inc.

Industry Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Teva Pharmaceuticals USA

Industry Sponsor

Trials
232
Recruited
189,000+

Dr. Eric A. Hughes

Teva Pharmaceuticals USA

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis profile image

Richard Francis

Teva Pharmaceuticals USA

Chief Executive Officer since 2023

BSc in Biochemistry from Imperial College London

Findings from Research

In a study involving 20 pediatric patients with low- and intermediate-risk Hodgkin lymphoma, a single-day dose of 180 mg/m2 of bendamustine was found to be safe and well tolerated, with no significant toxicities causing treatment delays.
Age was a factor influencing the clearance of bendamustine, accounting for 23% of variability among individuals, but this did not impact the overall safety and tolerability of the treatment.
Pharmacokinetics and safety of bendamustine in the BEABOVP regimen for the treatment of pediatric patients with Hodgkin lymphoma.Purvis, KN., Swanson, HD., Niloy, KK., et al.[2023]
The T(R)EC regimen, which replaces ifosfamide with bendamustine, demonstrated high response rates of 85% in classic Hodgkin lymphoma and 65% in diffuse large B cell lymphoma, indicating its efficacy as a treatment for relapsed or refractory cases.
This outpatient treatment was found to be safe, with no dose-limiting toxicities and successful stem cell collection in 30 out of 32 patients, making it a promising alternative to the traditional (R)ICE regimen.
Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial.Budde, LE., Wu, D., Martin, DB., et al.[2022]
The chemotherapy regimen combining MOPP/EBV/CAD resulted in a high response rate, with 93% of 80 patients achieving complete or partial remission for advanced Hodgkin's disease, demonstrating its efficacy.
While the treatment showed promising results, it also led to significant hematologic toxicity, including one fatal case of gastrointestinal bleeding, highlighting the need for caution in its application.
MOPP/EBV/CAD hybrid chemotherapy with or without limited radiotherapy in advanced or unfavorably presenting Hodgkin's disease: a report from the Italian Lymphoma Study Group.Gobbi, PG., Pieresca, C., Federico, M., et al.[2017]

References

Pharmacokinetics and safety of bendamustine in the BEABOVP regimen for the treatment of pediatric patients with Hodgkin lymphoma. [2023]
Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial. [2022]
MOPP/EBV/CAD hybrid chemotherapy with or without limited radiotherapy in advanced or unfavorably presenting Hodgkin's disease: a report from the Italian Lymphoma Study Group. [2017]
Efficacy and safety of front-line treatments for advanced Hodgkin lymphoma: a systematic literature review. [2021]
ABVD plus radiotherapy versus EVE plus radiotherapy in unfavorable stage IA and IIA Hodgkin's lymphoma: results from an Intergruppo Italiano Linfomi randomized study. [2020]
Safety and efficacy of netupitant/palonosetron and dexamethasone in classical Hodgkin's lymphoma patients with inadequate chemotherapy-induced nausea and vomiting prophylaxis with palonosetron and dexamethasone: a single-center real-life experience. [2020]
Comparison of antiemetic effects of granisetron and palonosetron in patients receiving bendamustine-based chemotherapy. [2019]
[Management of vomiting induced by polychemotherapy in Hodgkin's disease]. [2013]
Practice Patterns for Prevention of Chemotherapy-Induced Nausea and Vomiting and Antiemetic Guideline Adherence Based on Real-World Prescribing Data. [2021]
Difference in the emetic control among highly emetogenic chemotherapy regimens: Implementation for appropriate use of aprepitant. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A pilot study of etoposide, vinblastine, and doxorubicin plus involved field irradiation in advanced, previously untreated Hodgkin's disease. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Randomized comparison of ABVD chemotherapy with a strategy that includes radiation therapy in patients with limited-stage Hodgkin's lymphoma: National Cancer Institute of Canada Clinical Trials Group and the Eastern Cooperative Oncology Group. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and toxicity of vinblastine, bleomycin, and methotrexate with involved-field radiotherapy in clinical stage IA and IIA Hodgkin's disease: a British National Lymphoma Investigation pilot study. [2017]
14.United Statespubmed.ncbi.nlm.nih.gov
Trials in advanced Hodgkin's disease: more than 30 years experience of the British National Lymphoma Investigation. [2019]
15.United Statespubmed.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. [2021]
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