82 Participants Needed

Chemotherapy + Immunotherapy for Hodgkin's Lymphoma

Recruiting at 9 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Academic and Community Cancer Research United
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or medications that could interfere with the trial, you may need to stop them. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination including Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine for treating Hodgkin's Lymphoma?

Research shows that the combination of Brentuximab Vedotin with Doxorubicin, Vinblastine, and Dacarbazine (A+AVD) provides long-term benefits in progression-free survival for patients with advanced Hodgkin's Lymphoma, compared to the traditional ABVD regimen. This combination has shown potential benefits in overall survival, especially in patients with stage III or IV Hodgkin's Lymphoma.12345

Is the combination of chemotherapy drugs like doxorubicin, vinblastine, and dacarbazine safe for humans?

The combination of chemotherapy drugs doxorubicin, vinblastine, and dacarbazine was generally well tolerated in patients, with mild and temporary side effects. No increase in adverse events was observed when these drugs were used with NEPA, a medication to manage nausea and vomiting.678910

What makes the chemotherapy and immunotherapy drug combination unique for treating Hodgkin's Lymphoma?

This treatment combines chemotherapy drugs like doxorubicin and dacarbazine with immunotherapy drugs like nivolumab, which helps the immune system target cancer cells more effectively. Brentuximab vedotin, a key component, specifically targets CD30-positive cancer cells, which are common in Hodgkin's Lymphoma, making it a targeted approach compared to traditional chemotherapy regimens.1351112

What is the purpose of this trial?

This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.

Research Team

SI

Steven I Park

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

This trial is for adults with previously untreated stage I-II non-bulky Hodgkin lymphoma. Participants must have measurable disease, adequate blood counts and organ function, no severe infections or other health conditions that could interfere with the study, not be pregnant or nursing, and agree to use contraception. Those with certain prior treatments, immunodeficiency, active hepatitis B or C, another primary malignancy within 3 years (with some exceptions), uncontrolled illnesses or known allergies to study drugs are excluded.

Inclusion Criteria

My hemoglobin level is at least 8.5 g/dL without recent blood transfusions.
My white blood cell count is healthy without needing a recent blood transfusion.
My cancer can be measured and is at least 1.5 cm big on a CT scan.
See 14 more

Exclusion Criteria

I have a large tumor (10 cm or larger) according to a CT scan.
I am not taking any experimental drugs for my cancer.
I have not had severe infections, pancreatitis, stroke, or TIA in the recent past.
See 26 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin every 28 days for 3 cycles

12 weeks
6 visits (in-person)

Consolidation Therapy

PET-positive participants receive brentuximab vedotin and nivolumab every 2 weeks for 4 cycles, followed by nivolumab alone for 8 cycles; PET-negative participants receive nivolumab every 2 weeks for 8 cycles

24 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Follow-up at 4 and 8 weeks, every 3 or 6 months for 2 years, then annually for 3 years

Treatment Details

Interventions

  • Brentuximab Vedotin
  • Dacarbazine
  • Doxorubicin
  • Nivolumab
  • Vinblastine
Trial Overview The trial tests a combination of chemotherapy drugs (doxorubicin, vinblastine, dacarbazine) alongside brentuximab vedotin and nivolumab in patients with early-stage Hodgkin lymphoma. The aim is to see if this regimen can improve survival by killing cancer cells directly while also boosting the immune system's ability to fight cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy, nivolumab)Experimental Treatment6 Interventions
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over \>= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Adcetris for:
  • Hodgkin lymphoma
  • Systemic anaplastic large cell lymphoma
  • Primary cutaneous anaplastic large cell lymphoma
  • CD30-expressing mycosis fungoides
  • Peripheral T-cell lymphoma
🇪🇺
Approved in European Union as Adcetris for:
  • Hodgkin lymphoma
  • Systemic anaplastic large cell lymphoma
  • Cutaneous T-cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials
54
Recruited
4,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a phase II trial involving 170 patients with early-stage unfavorable Hodgkin lymphoma, the combination of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (BV-AVD) resulted in a higher PET-negative response rate (82.3%) after two cycles compared to the standard ABVD treatment (75.4%).
The 2-year progression-free survival (PFS) rate was also higher in the BV-AVD group (97.3%) compared to the ABVD group (92.6%), indicating that BV-AVD may offer a more effective treatment option for these patients.
Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial.Fornecker, LM., Lazarovici, J., Aurer, I., et al.[2023]
In the phase III ECHELON-1 study involving 1,334 patients, older patients (aged ≥60) with classical Hodgkin lymphoma showed similar modified progression-free survival rates at 24 months when treated with brentuximab vedotin plus AVD (70.3%) compared to ABVD (71.4%).
While A+AVD demonstrated comparable efficacy to ABVD, it was associated with higher rates of grade 3/4 peripheral neuropathy (18% vs. 3%) and febrile neutropenia (37% vs. 17%), but lower rates of pulmonary toxicity, with no pulmonary-related deaths in the A+AVD group.
Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study.Evens, AM., Connors, JM., Younes, A., et al.[2022]
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.
Efficacy and safety of front-line treatments for advanced Hodgkin lymphoma: a systematic literature review.Dalal, M., Gupta, J., Price, K., et al.[2021]

References

Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. [2023]
Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. [2022]
Efficacy and safety of front-line treatments for advanced Hodgkin lymphoma: a systematic literature review. [2021]
Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. [2022]
Safety and efficacy of single-agent bendamustine after failure of brentuximab vedotin in patients with relapsed or refractory hodgkin's lymphoma: experience with 27 patients. [2019]
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]
Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy. [2018]
A prospective study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in malignant lymphoma patients following highly emetogenic chemotherapy. [2018]
[The efficacy and safety of indisetron hydrochloride for the management of nausea/vomiting caused by chemotherapy for gynecologic cancer]. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy. [2021]
11.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]
Brentuximab vedotin: a review of its use in patients with hodgkin lymphoma and systemic anaplastic large cell lymphoma following previous treatment failure. [2021]
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