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Anti-metabolites

Chemotherapy + Immunotherapy for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Ryan Lynch

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 30/ml per minute by Cockcroft Gault formula

Patients should not have evidence of active central nervous system lymphoma

Must not have

Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen

Active ischemic heart disease or congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat classical Hodgkin lymphoma. The drugs work in different ways to stop the growth of cancer cells. The combination may work better than each drug alone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include damage to the heart muscle from doxorubicin hydrochloride; immune system changes causing inflammation in various organs due to pembrolizumab; blood cell count issues; fatigue; and nausea from chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is within the required range.

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I do not have active brain lymphoma.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My Hodgkin lymphoma has not been treated before.

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I can undergo at least 2 cycles of ABVD or AVD chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have heart disease or heart failure.

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I have or had lung inflammation that needed steroids.

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I am known to be positive for HIV or hepatitis B/C.

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I use supplemental oxygen.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PART A: Number of participants who complete of 2 cycles of adriamycin, pembrolizumab, vinblastine and dacarbazine (APVD)

PART B: Event Free Survival at 1 year

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (APVD)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Dacarbazine

2005

Completed Phase 3

~5350