Hodgkin Lymphoma
Conditions
Brief summary
The purpose of this trial is 1. to determine the recommended dose of everolimus for a subsequent Phase II trial 2. to determine the efficacy of everolimus plus DHAP
Interventions
DRUGEverolimus
DRUGDHAP
Dexamethasone, Cytarabine, Cisplatin
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* relapsed or refractory Hodgkin Lymphoma * age 18-60 * histology confirmed relapse
Exclusion criteria
* previous therapy with mTOR inhibitor * current CNS involvement * other primary malignant disease within the last 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate (CR) | 4 weeks | Phase II primary outcome measure |
| Dose Limiting Toxicity Rate (DLT) | 4 weeks | Phase I primary outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 4 weeks | Phase I secondary outcome measure |
| Tumor status (assessed by CT) after chemotherapy | 4 weeks | Phase II secondary outcome measure |
| Tumor status (assessed by PET) after chemotherapy | 4 weeks | Phase II secondary outcome measure |
Countries
Germany
Outcome results
None listed