Peripheral T-Cell Lymphoma
Conditions
Brief summary
The primary endpoint is PFS, defined as the time (months) from randomization to the first documented PD or death, whichever occurs first.
Detailed description
• Overall survival is defined as time from randomization to death due to any cause. Overall survival will be censored at the date patients were last known to be alive. • Objective response rate is defined as the percentage of patients who have a CR or PR as their best objective response. • Treatment compliance- Dose delays and reduction of the treatment arms will be evaluated.
Interventions
DRUGPralatrexate
DRUGDOXORUBICIN
DRUGPREDNISONE
DRUGCYCLOPHOSPHAMIDE
DRUGVINCRISTINE SULFATE
DRUGBelinostat
Sponsors
Acrotech Biopharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is PFS, defined as the time (months) from randomization to the first documented PD or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival is defined as time from randomization to death due to any cause. Overall survival will be censored at the date patients were last known to be alive. • Objective response rate is defined as the percentage of patients who have a CR or PR as their best objective response. • Treatment compliance- Dose delays and reduction of the treatment arms will be evaluated. | — |
Countries
Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed