Study of brentuximab vedotin combined with RCHOP or RCHP for front-line treatment of patients with diffuse large B-cell lymphoma (DLBCL)
- Conditions
- Diffuse large B-cell lymphoma (DLBCL)MedDRA version: 20.0Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004741-54-IT
- Lead Sponsor
- SEATTLE GENETICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1.Treatment-naive patients with systemic de novo or transformed DLBCL, or follicular NHL grade 3b; patients must have high-intermediate or high risk disease based on standard IPI (score =3 for patients >60 years of age) or aaIPI (score 2 or 3 for patients =60 years of age), and stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB–IV disease
2.Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist
3.An Eastern Cooperative Oncology Group (ECOG) performance status =2
4.Age 18 years or older
5.Patients must have the following baseline laboratory data:
?bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert's disease or documented hepatic involvement with lymphoma
?alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3X ULN or =5X ULN for patients with documented hepatic involvement with lymphoma
?serum creatinine =2X ULN
?absolute neutrophil count (ANC) =1000/µL (unless documented bone marrow involvement with lymphoma)
?platelet count =50,000/µL (unless documented bone marrow involvement with lymphoma)
6.Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are post menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy.
7.Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraception methods during the study and for 12 months following the last dose of study drug
8.Patients or their legally authorized representative must provide written informed consent
9.Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
1.Previous history of treated indolent lymphoma. Newly diagnosed patients with DLBCL who are found to have small cell infiltration of the bone marrow or other diagnostic material (representing a discordant lymphoma) are eligible.
2.History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
3.History of progressive multifocal leukoencephalopathy (PML)
4.Cerebral/meningeal disease related to the underlying malignancy
5.Baseline peripheral neuropathy >/= Grade 2 (per the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 4.03) or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
6.Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months or previous treatment with complete cumulative doses of doxorubicin or other anthracyclines
7.Any active Grade 3 or higher (per the NCI CTCAE, Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
8.Current therapy with other systemic anti-neoplastic or investigational agents
9.Females who are breastfeeding
10.Known hypersensitivity to any excipient contained in any of the drug formulations of study treatments
11.Patients with known urinary outflow obstruction
12.Known human immunodeficiency virus (HIV) infection or known or suspected active hepatitis C infection. Patients with a positive hepatitis B polymerase chain reaction (PCR) assay who have also tested positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody; patients with a negative PCR assay are permitted with effective anti-viral prophylaxis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method