Treatment of older patients with newly diagnosed classical Hodgkin lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: ADCETRIS
Product Name: Adcetris
Pharmaceutical Form: Lyophilisate for solution for infusion
Trade Name: Adrimedac
Product Name: Adrimedac
Pharmaceutical Form: Solution for injection/infus
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: B-CAP group: -Histologically proven classical Hodgkin lymphoma -First diagnosis, no previous treatment except prephase as outlined -Age: 60 years or older -Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease -ECOG performance status = 2 or = 3 if due to HL -CIRS-G score of = 6 and = 3 per organ system (except score 4 for eye, ear, nose and throat) -Negative HIV test -Screening laboratory values must meet the following criteria: Hemoglobin =8.0 g/dl, WBC =1500/µl; neutrophils =1500/µl; platelets =75,000/µl (Unless due to HL) Alkaline phosphatase 40 ml/min as estimated by the Cockroft-Gault formula* -Life expectancy > 3 months Brentuximab vedotin single agent group: -Histologically proven classical Hodgkin lymphoma -First diagnosis, no previous treatment -Age: 60 years or older stage IA to IVB -CIRS-G score of = 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat) -Patients not eligible to curative poly-chemotherapy at the investigators judgment -Negative HIV test -Screening laboratory values must meet the following criteria: Hemoglobin =8.0 g/dl, WBC =1500/µl; neutrophils =1500/µl; platelets =75,000/µl (Unless due to HL) Alkaline phosphatase 40 ml/min as estimated by the Cockroft-Gault formula* 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: B-CAP group: -Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) -Prior chemotherapy or radiation for HL except prephase as outlined in the protocol -Prior chemotherapy containing anthracyclines -Concurrent disease which precludes protocol treatment, in particular the following conditions: Chronic obstructive pulmonary disease (requiring = 2 inpatient treatments due to exacerbation within 1 year); History of myocardial infarction = 6 months prior to first dose of study drug; Symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2, or any other cardiac condition (e.g. pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed; Heart failure = NYHA II and/or EF 6 months) ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate) -Peripheral neuropathy greater than CTC Grade 1 -Patient’s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly -Non-compliance General intolerance of any protocol medication Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator -Committal to an institution on judicial or official order Participation in another interventional trial that could interact with this trial Brentuximab vedotin single agent group: -Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) -Prior chemotherapy or radiation for HL except prephase as outlined in the protocol -Ongoing long-term (i.e. >6 months) ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate) -Peripheral neuropathy greater than CTC Grade 1 -Patient’s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly -Non-compliance General intolerance of any protocol medication Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator -Committal to an institution on judicial or official order -Participation in another interventional trial that could interact with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to show efficacy of B-CAP and brentuximab vedotin monotherapy;Secondary Objective: Secondary objectives are to show the safety and feasibility of B-CAP and brentuximab vedotin.;Primary end point(s): Primary endpoint of the study is the objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy.;Timepoint(s) of evaluation of this end point: see E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include the complete remission rate assessed after the end of treatment, progression-free survival (PFS) at three years, overall survival (OS), OSHL and PFSHL at three years (defined as OS and PFS but deaths for known reasons other than HL or toxicity of treatment are censored and not considered as failures), the frequency of adverse events and the relative dose intensity of the novel brentuximab vedotin-containing B-CAP regimen or brentuximab vedotin.;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Denmark, Finland, Germany, Norway, Sweden
Contacts
Public ContactGerman Hodgkin Study Group
German Hodgkin Study Group
Outcome results
None listed