Immunochemotherapy as new treatment for older Patients with Hodgkin Lymphoma

Phase 1

Active, not recruiting

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-DK

Lead Sponsor: niversity of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not 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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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