Immunochemotherapy as new tratment for older patients with Hodgkin Lymphoma

Phase 1

• Conditions: Treatment of older patients with newly diagnosed classical Hodgkin lymphoma; MedDRA version: 18.1Level: 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-FI
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-29
• Last Update Posted: 30 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