Classical Hodgkin Lymphoma
Conditions
Brief summary
The aim of the trial is to improve 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) for up to one year. The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
Interventions
DRUGBrentuximab Vedotin
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Sponsors
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Presence of nodular lymphocyte-predominant HL (NLPHL) or 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Cumulative incidence of relapse (CIR) | 1 year | 1-year Cumulative incidence of relapse (CIR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1- and 2-year Progression-free survival (PFS) | 1 and 2 years | 1- and 2-year Progression-free survival (PFS) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORChristof Scheid, Prof.
University of Cologne, I. Dept. of Medicine
Outcome results
None listed