Trials / Terminated
TerminatedNCT02495454
GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma
GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma A Phase II Study of the Fondazione Italiana Linfomi (FIL)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Fondazione Italiana Linfomi - ETS · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.
Detailed description
Considering that the treatment of elderly unfit patients with DLBCL cannot be based on a full course of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), and that using a less intense R-miniCHOP (an attenuated version of the standard R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) combination an acceptable cure rate can be achieved this study is designed to try to improve the cure rate in unfit patients with DLBCL (Diffuse Large B Cell Lymphoma) by adopting the R-miniCHOP scheme substituting Rituximab with the more active GA101 monoclonal antibody. The study hypothesis is that a higher activity of the treatment can be achieved without modifying the cytotoxic part of the treatment but using a more active immunotherapy. Differently from the previous experience with R-miniCHOP eligible patient are not only identified using anagraphic criteria but adopting CGA (Comprehensive Geriatric Assessment) as part of initial assessment and considering as eligible unfit patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ga101 |
Timeline
- Start date
- 2015-08-25
- Primary completion
- 2017-03-22
- Completion
- 2017-03-22
- First posted
- 2015-07-13
- Last updated
- 2020-11-05
- Results posted
- 2020-11-05
Locations
16 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02495454. Inclusion in this directory is not an endorsement.