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Phase 2 N=50 Treatment

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

Classical Hodgkin Lymphoma

Enrolled (actual)
50
Serious AEs
16.0%
Results posted
Jan 2025
Primary outcome: Primary: PART A: Number of Participants Who Complete of 2 Cycles of Adriamycin, Pembrolizumab, Vinblastine and Dacarbazine (APVD) — 30 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Dacarbazine (Drug); Doxorubicin Hydrochloride (Drug); Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological); Vinblastine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
PART A: Number of Participants Who Complete of 2 Cycles of Adriamycin, Pembrolizumab, Vinblastine and Dacarbazine (APVD)
30
PRIMARY
PART B: Event Free Survival at 1 Year
49
SECONDARY
Proportion of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography PET2 Negative (Deauville Score 1-3) Patients After 2 Cycles of APVD
30

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.

Eligibility Criteria

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)
  • 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 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1 year

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03331341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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