Chemotherapy + Immunotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Ryan Lynch, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine in treating patients with classical Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with pembrolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine may work better in treating classical Hodgkin lymphoma.

Eligibility Criteria

This trial is for patients with untreated classical Hodgkin lymphoma. Eligible participants include those who are not pregnant, agree to use birth control, have a good performance status (able to carry out daily activities), and adequate organ function. It's not open to individuals with severe heart conditions, active infections, other cancers (except certain skin or in situ cancers), HIV/hepatitis B/C, or those on oxygen therapy.

Inclusion Criteria

My hemoglobin level is at least 8 g/dL.

My kidney function is within the required range.

Absolute neutrophil count (ANC) >= 1,500/mm^3 (without transfusion or growth factor support)

Exclusion Criteria

I am not pregnant or nursing and will use effective birth control if I can have children.

I do not have severe health issues that would prevent me from receiving strong chemotherapy.

I have had cancer before, but it was either skin cancer treated successfully, breast or cervical cancer that did not spread, or any cancer I've been free from for over 5 years.

Participant Groups

The study tests the effectiveness of combining chemotherapy drugs doxorubicin hydrochloride, vinblastine, dacarbazine with immunotherapy drug pembrolizumab in treating Hodgkin lymphoma. The goal is to see if this combination helps stop cancer cells from growing by killing them directly or disrupting their spread.

Group I: Treatment (APVD) Experimental Treatment 5 Interventions

PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.

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

🇺🇸 Approved in United States as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

🇪🇺 Approved in European Union as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

🇨🇦 Approved in Canada as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Fred Hutch/University of Washington Cancer Consortium Seattle, WA

Who Is Running the Clinical Trial?

University of Washington Lead Sponsor

References