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NCT03331341CompletedPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
50 (actual)
First submitted
31 Oct 2017
Start date
9 Jan 2019
Primary completion date
21 Dec 2023
Lead sponsor
University of Washington
NCT number
NCT03331341

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 50
  • From 9 Jan 2019 to the primary completion date, 21 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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
  • 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

Other illness

  • Patients known positive for human immunodeficiency virus (HIV), or infectious hepatitis type B or C
  • 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
  • Active ischemic heart disease or congestive heart failure

Other

  • Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Current use of supplemental oxygen

Who the study is looking for

  • 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)
  • Platelets \>= 100,000/mm\^3 (without transfusion or growth factor support)
  • Hemoglobin \>= 8 g/dL. Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement
  • Serum creatinine \< 1.5 mg/dl or creatinine clearance greater than 30/ml per minute by Cockcroft Gault formula
  • Total bilirubin =\< 1.5 times upper limit of normal OR direct bilirubin =\< upper limit of normal (ULN) for participants with total bilirubin levels \> 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal (=\< 5 x ULN for participants with liver metastases)
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Patients must be anticipated to complete all planned study therapy
  • Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.