Acronym:
Chronos 4
ACTRN/NCT /ethics:
NCT02626455
Scientific title:
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Summary of trial and patient characteristics
| Cancer Type | Lymphoma | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase III | Tumour Stream | non-Hodkin's Lymphoma |
| Age Range | 18 years and older | Cancer Stage | Locally Recurrent or Locally Advanced |
| Sex | Both | Anticipated Start Date | 2016-01-06 |
| Molecular Target | Anticipated End Date | 2024-12-31 | |
| Cancer Type | Lymphoma |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | non-Hodkin's Lymphoma |
| Cancer Stage | Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2016-01-06 |
| Anticipated End Date | 2024-12-31 |
Trial Summary
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, incristine and prednisone/prednisolone [R-CHOP]) is effective and safe compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab and alkylating agents.
Lay Summary
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Sponsor / Cooperative group
Bayer
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Ashford Cancer Centre Research | Sue Yeend | syeend@adelaidecancercentre.com.au | 08 8292 2240 | Dr Nicholas Wickham | Recruiting |