A trial to improve disease control after an allogeneic stem cell transplantation for relapsed or refractory classical Hodgkin lymphoma with consolidation therapy by Brentuximab Vedoti
Phase 1
- Conditions
- disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV)MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000873-59-DE
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
?- Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
?- Histologically proven cHL in the most recent tumor biopsy
?- Absolute neutrophil count = 500/mm³
?- ECOG =2
?- Age = 18 years
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
?- Presence of nodular lymphocyte-predominant HL (NLPHL)
- grey-zone lymphoma
?- Progressive disease as last documented response prior to alloSCT
?- Any peripheral neuropathy = grade 2
?- Any other serious disease or organ dysfunction which might impair protocol Treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method