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Clinical Trials/EUCTR2013-003990-89-NO
EUCTR2013-003990-89-NOActive, not recruitingPhase 1

Brentuximab vedotin or B-CAP in the treatment of older patients with newly diagnosed classical Hodgkin Lymphoma – a GHSG-NLG Intergroup Phase II trial –

niversity of Cologne0 sites70 target enrollmentStarted: October 19, 2015Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
70
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity of Cologne

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