Relapsed or refractory peripheral T-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10042980 Term: T-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10042979 Term: T-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ADCETRIS
Product Name: Brentuximab vedotin
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: Brentuximab vedotin
CAS Number: 914088-09-8
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and females of 18 years to 80 years of age - Understand and voluntarily sign an informed consent document prior to any study related assessment or procedure - Patients able to adhere to the study visit schedule and protocol requirements - Patients with histologically proven, CD30 positive (at least 5% of cells according to local examination) peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification for whom gemcitabine treatment is expected. A biopsy at relapse is highly recommended - Patients who have evidence of relapsed disease after at least one line (and no more than three lines) of treatment or who were refractory to a first or subsequent line of treatment - Patients with Ann Arbor stage I – IV - Patients with ECOG performance status of 0 - 2 - Patients with at least one measurable disease, i.e. one nodal or extra-nodal lesion of 1.5 cm or more - Negative pregnancy test for females of childbearing potential (FCBP) - Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 6 months thereafter - Males must use an effective method of birth control during treatment period and 6 months thereafter Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Any significant medical condition or laboratory abnormality unrelated to PTCL, or psychiatric illness that would prevent the patient from participating in the study and from signing the informed consent form - Any condition that confounds the ability to interpret data from the study - Other types of lymphomas, e.g. B-cell lymphoma - Central nervous system and/or meningeal involvement by PTCL - Signs or symptoms of Progressive Multifocal Leukoencephalopathy - Preexistent peripheral neuropathy = grade 2, whatever the cause - Contraindication to any drug contained in the chemotherapy regimen - Subjects with HIV or HTLV1 positivity - Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible - Chronic or acute, clinically significant, untreated bacterial, viral or fungal infection - Any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) 1.5 x ULN e. Serum lipase level > 2 x ULN f. Serum creatinine > 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance < 40 mL/minute g. Hemoglobin < 8g/dL - Active malignancies other than PTCL requiring systemic treatment - Previous treatment with brentuximab vedotin - Previous treatment with gemcitabine - Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study - Known history of any of the following cardiovascular conditions: o Myocardial infarction within 2 years of enrollment o New York Heart Association (NYHA) Class III or IV heart failure o Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities o Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% - Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment - Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. - Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of brentuximab vedotin (BV) in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 – CT-Based Response).;Secondary Objective: To determine : -the efficacy of BV in patients with relapsed or refractory peripheral T-cell lymphoma treated with gemcitabine, in term of progression free survival (PFS), complete response rate (CRR), duration of response for responding patients (DR), time to treatment failure (TTF), time to next treatment (TTNT) and overall survival (OS) - the efficacy of maintenance with BV in terms of PFS, DR and OS - the overall response rate (ORR) according to FDG-PET scan assessment - the toxicity of BV in patients with relapsed or refractory peripheral T-cell lymphoma treated with gemcitabine according to the NCICTCAE v4.03 -the toxicity of maintenance with BV according to the NCICTCAE v4.03 ;Primary end point(s): ORR according to Lugano Classification 2014 – CT-Based Response;Timepoint(s) of evaluation of this end point: after 4 cycles of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response rates (RR) according to the response criteria for malignant lymphoma 2014 - Overall Metabolic Response Rate (OMRR) according to FDG-PET scan assessment - Progression Free Survival (PFS) - Duration of response (DR) - Time to Treatment Failure (TTF) - Time to next treatment (TTNT) - Overall Survival (OS) - Safety;Timepoint(s) of evaluation of this end point: 1. Efficacy assessments Tumor assessment will be performed at baseline, after the second cycle and at the end of GBv treatment or at permanent treatment discontinuation. During BV maintenance : every three cycles of BV. Follow-up assessment : every 3 months the first 2 years and every 6 months thereafter. 2. Safety assessments throughout the study. | — |
Countries
Belgium
Contacts
Public ContactProject Manager J. Diou-Lefort
LYSARC
Outcome results
None listed