Chemotherapy + Immunotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen bySteven I Park

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

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.

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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.

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Treatment Details

Interventions

Brentuximab Vedotin (Monoclonal Antibodies)
Dacarbazine (Antitumor Antibiotic)
Doxorubicin (Antitumor Antibiotic)
Nivolumab (Monoclonal Antibodies)
Vinblastine (Vinca Alkaloids)

Trial OverviewThe 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.