Phase
Condition
Non-hodgkin's Lymphoma
Lymphoma
Treatment
Prednisone
Cyclophosphamide
Doxorubicin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have newly diagnosed CD30+ PTCL, per the Revised European AmericanLymphoma 2016 World Health Organization (WHO) classification, by local assessment.Tumor specimen must be submitted before enrollment for subsequent central pathologyreview to confirm histology (and anaplastic lymphoma kinase (ALK) status, ifapplicable), and CD30 expression. Eligible histologies include:
ALK-positive systemic anaplastic large cell lymphoma (sALCL) with anInternational Prognostic Index (IPI) score of ≥2.
ALK-negative sALCL.
PTCL- not otherwise specified (NOS).
Angioimmunoblastic T-cell lymphoma (AITL).
Enteropathy associated T-cell lymphoma (EATL).
Hepatosplenic T-cell lymphoma (HSTCL).
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equalto 2.
Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) imagingand measurable disease with at least 1 bidimensionally measurable lesion (>1.5 cm inits largest dimension) by computed tomography (CT).
Suitable venous access for the study-required blood sampling, includingpharmacokinetic (PK) and immunogenicity sampling.
Clinical laboratory values as specified below at screening/baseline within 7 daysbefore the first dose of study drug:
Total bilirubin must be ≤1.5 times the upper limit of normal (ULN) or ≤3 timesthe ULN for participants with Gilbert's disease or documented hepaticinvolvement with lymphoma.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤3times the ULN or ≤5 times the ULN for participants with an elevation that canbe reasonably ascribed to the presence of metastatic disease in liver.
Serum creatinine must be <2.0 milligram per deciliter (mg/dL) and/or creatinineclearance or calculated creatinine clearance >40 milliliter (mL)/minute.
Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusionis allowed ≥14 days before assessment.)
Absolute neutrophil count >1.5×10^9/liter (L).
Platelet count ≥75×10^9/L (unless documented bone marrow involvement withlymphoma).
Exclusion
Exclusion Criteria:
Systemic anticancer therapy, including traditional Chinese medicine with antitumorindication for disease under study before the first dose of study drugs.
Major surgery within 28 days before the first dose of study drug.
Known human immunodeficiency virus (HIV)-positive status.
Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or activehepatitis C virus infection. Note: Participants who have positive HBV core antibody and are HBsAg negative can beenrolled, but must have an undetectable HBV viral load.
Diagnosed or treated for another malignancy within 3 years before the first dose orpreviously diagnosed with another malignancy and have any evidence of residualdisease. Participants with nonmelanoma skin cancer or carcinoma in situ of any typeare not excluded if they have undergone complete resection.
Any of the following cardiovascular conditions or values within 6 months before thefirst dose of study drug:
Left-ventricular ejection fraction <45%.
Myocardial infarction within 6 months of enrollment.
New York Heart Association Class III or IV heart failure.
Participants with current diagnosis of primary cutaneous CD30+ T-celllymphoproliferative disorders and lymphomas. Participants with cutaneous anaplasticlarge cell lymphoma (ALCL) with extracutaneous tumor spread beyond locoregionallymph nodes are eligible (previous single-agent treatment to address cutaneous andlocoregional disease is permissible).
Participants with mycosis fungoides (MF) [including transformed MF].
Uncontrolled diabetes mellitus.
Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute CommonTerminology Criteria for Adverse Events [NCI CTCAE], version 5.0).
History of progressive multifocal leukoencephalopathy (PML).
Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, 100142
ChinaSite Not Available
Peking University Third Hospital
Beijing, 100191
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, 400030
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
Guangdong Provincial Peoples Hospital
Guangzhou, 510080
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, 310003
ChinaSite Not Available
Anhui Provincial Cancer Hospital
Hefei, 230088
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, 250117
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, 200032
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, 110022
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, 215004
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450003
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.