CHRONOS-4 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-75Age 18-75

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Follicular Lymphoma

Trial Overview Read MoreRead more

This phase III trial is adding the investigational drug copanlisib, to standard immunochemotherapy (R-B or R-CHOP) for patients with Non Hodgkin Lymphoma.
 

This trial is treating patients with B-Cell Non Hodgkin Lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Commercial Sponsor

Bayer Inc

Summary

Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen). This study will be composed of two parts: Safety run-in and phase III part. The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study will start when the recommended dose of copanlisib in combination with R-CHOP and R-B has been defined and confirmed by sponsor, principal **Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to: - Follicular lymphoma G1-2-3a - Small lymphocytic lymphoma with absolute lymphocyte count <5x109 at="" the="" time="" of="" diagnosis="" and="" at="" study="" entry="" -="" lymphoplasmacytoid="" lymphoma/waldenstrã¶m="" macroglobulinemia="" (lpl/wm)="" -="" marginal="" zone="" lymphoma="" (splenic,="" nodal,="" or="">

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Flora Yuen
flora.yuen@alfred.org.au
03 9076 5407

Box Hill Hospital, Malignant Haematology
Box Hill
Ms Lesley Poulton
lesley.poulton@monash.edu
03 9094 9502

Not Recruiting Hospitals Read MoreRead more

Not currently recruiting

Frankston Hospital
Frankston
Ms Judy Reilly
judithreilly@phcn.vic.gov.au
03 9784 8520

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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