Classical Hodgkin Lymphoma
Conditions
Brief summary
The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD). The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
Interventions
DRUGDacarbazine
Infusion of Dacarbazine
DRUGNivolumab
Infusion of Nivolumab
DRUGAdriamycin
Infusion of Adriamycin
DRUGVinblastine
Infusion of Vinblastine
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven classical HL * First diagnosis, no previous treatment * Age: 18-60 years * Stage I, IIA with risk factors a-d, IIB with RF c-d: 1. large mediastinal mass 2. extranodal lesions 3. elevated ESR 4. ≥ 3 nodal areas confirmed by central review.
Exclusion criteria
* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) * History of other malignancy ≤ 5 years * Prior chemotherapy or radiation therapy * Concurrent disease precluding protocol treatment * Pregnancy, lactation * Non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission Rate | 4 to 6 weeks after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related Morbidity | 1 year after end of treatment |
| Progression Free Survival | 1 and 3 years after end of treatment |
| Overall Survival | 1 and 3 years after end of treatment |
Countries
Germany
Outcome results
None listed