Immunochemotherapy as new treatment for older Patients with Hodgkin Lymphoma

Phase 1

• Conditions: Treatment of older patients with newly diagnosed classical Hodgkin lymphoma; MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003990-89-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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 <3 ULN, AST or ALT <3 ULN, serum total bilirubin =1.5 ULN (unless diagnosed with Gilbert’s Syndrome)* INR 2 and an aPTT 2 ULN unless due to anticoagulation Creatinine clearance > 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 <3 ULN, AST or ALT <3 ULN, serum total bilirubin =1.5 ULN (unless diagnosed with Gilbert’s Syndrome)* INR 2 and an aPTT 2 ULN unless due to anticoagulation Creatinine clearance > 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

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 <50% (MUGA scan or echocardiography); Uncontrolled hypertension despite appropriate medication; Uncontrolled active infection; Chronic active or persisting (positive PCR) hepatitis B and/or hepatitis C
-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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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