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Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma

A Pilot Trial of Adriamycin, Pembrolizumab, Vinblastine, and Dacarbazine (APVD) for Patients With Untreated Classical Hodgkin Lymphoma

NCT03331341•University of Washington

View on ClinicalTrials.gov

Summary

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.

Detailed Description

OUTLINE: 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. After completion of study treatment, patients are followed up at 30 days and then up to 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have cHL that has not been previously treated
•* Part A: Any stage
•* Part B: Must be stage 3 or 4
•Patients must be appropriate candidates for at least 2 cycles of doxorubicin hydrochloride (adriamycin), bleomycin, vinblastine and dacarbazine (ABVD) (6 cycles for Part B patients) or doxorubicin hydrochloride, vinblastine, dacarbazine (AVD) (this could include patients ranging from favorable risk early stage disease to poor prognosis advanced stage disease)
•Patients must have measurable FDG-avid disease defined by standard criteria (Lugano 2014) and a minimum of 1.0 cm in diameter
•Patients should not have evidence of active central nervous system lymphoma
•Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Patients must have a left ventricular ejection (LVEF) \>= 50% within 56 days of enrollment
•Patients must have adequate labs within 10 days of treatment
•Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (without transfusion or growth factor support)
+10 more criteria

Exclusion Criteria

•Patients known positive for human immunodeficiency virus (HIV), or infectious hepatitis type B or C
•Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
•Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol chair or co-chair
•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
•Concurrent use of other anti-cancer agents or experimental treatments
•Known current or prior autoimmune disease with the exception of vitiligo
•Active or prior history of pneumonitis/interstitial lung disease that required corticosteroids
•Current use of supplemental oxygen
•Is known to have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Administration of killed vaccines is allowed

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

January 9, 2019

Primary Completion Date

December 21, 2023

Completion Date

December 21, 2023

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

Classical Hodgkin Lymphoma

Interventions

Dacarbazine

DRUG

Doxorubicin Hydrochloride

DRUG

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

BIOLOGICAL

Vinblastine

DRUG

European Project for ctDNA Detection as a Biomarker for Non-invasive Therapy Monitoring in Paediatric Classical Hodgkin Lymphoma

NCT07356882

Classical Hodgkin Lymphoma

View study

RECRUITINGPHASE1

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

NCT05362773

Leukemia, Acute MyeloidMyelodysplastic Syndromes+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

European Project for ctDNA Detection as a Biomarker for Non-invasive Therapy Monitoring in Paediatric Classical Hodgkin Lymphoma

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

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