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Alkylating agents

Copanlisib + Immunochemotherapy for Non-Hodgkin's Lymphoma (CHRONOS-4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after last patient´s first treatment
Awards & highlights

CHRONOS-4 Trial Summary

This trial is testing whether a new drug, copanlisib, is effective and safe when used with standard immunochemotherapy (R-B or R-CHOP) to treat patients with relapsed iNHL who have received 1-3 lines of treatment including rituximab-based immunochemotherapy and alkylating agents.

Eligible Conditions
  • Non-Hodgkin Lymphoma

CHRONOS-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after last patient´s first treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after last patient´s first treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase III_Evaluation whether copanlisib in combination with standard immunochemotherapy is superior to placebo and standard immunochemotherapy assessed by the prolongation of progression free survival (PFS)
Safety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse events
Secondary outcome measures
Phase III_Complete tumor response rate (CRR)
Phase III_Disease control rate (DCR)
Phase III_Duration of tumor response (DOR)
+9 more

CHRONOS-4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Copanlisib + R-B or R-CHOP / Arm 1Experimental Treatment7 Interventions
Combination of copanlisib with standard immunochemotherapy (rituximab and bendamustine) [R-B] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP] (safety run-in and phase III)
Group II: Placebo + R-B or R-CHOP / Arm 2Placebo Group7 Interventions
Combination of placebo and R-B or R-CHOP (phase III only)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Bendamustine
2015
Completed Phase 3
~2950
Cyclophosphamide
1995
Completed Phase 3
~3770
Rituximab
1999
Completed Phase 4
~1880
Vincristine
2003
Completed Phase 4
~2910
Doxorubicin
2012
Completed Phase 3
~7940
Copanlisib (BAY80-6946)
2014
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,431 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,392 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02626455 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: Placebo + R-B or R-CHOP / Arm 2, Copanlisib + R-B or R-CHOP / Arm 1
Non-Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT02626455 — Phase 3
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02626455 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar medical studies that have used Rituximab?

"Currently, there are 1536 ongoing studies researching Rituximab with 320 trials in Phase 3. While several of the trials for Rituximab are running out of in Majadahonda, Madrid, there are 54004 locations operating studies for Rituximab."

Answered by AI

What is the official government stance on Rituximab?

"There is some evidence, from Phase 3 trials, to support the efficacy of Rituximab and multiple rounds of data have been collected to support its safety--giving it a score of 3."

Answered by AI

Are there any available positions for volunteers in this experiment?

"This study, as detailed on clinicaltrials.gov, is not currently looking for new patients to enroll. The trial was first posted on January 6th, 2016 and last updated November 8th, 2022. There are 3325 other trials that are actively recruiting at this time."

Answered by AI

How many study participants are involved in this research?

"Unfortunately, this trial is not looking for new patients at the moment. It was first posted on 1/6/2016 and most recently updated on 11/8/2022. However, there are alternative clinical trials that might be of interest; 1789 studies are actively recruiting participants with lymphoma, diffuse and 1536 studies involving Rituximab are also currently seeking patients."

Answered by AI

For what treatments is Rituximab most often prescribed?

"Rituximab is the go-to treatment for leukemia. However, this medication can also be helpful in managing ophthalmia, sympathetic, therapeutic procedure, and lung cancers."

Answered by AI

In how many different medical clinics is this medical study being run today?

"Presently, this clinical trial is welcoming patients at Memorial Sloan Kettering Cancer Center in New york, NY; SCL Health Research at St Joseph's Hospital Denver co in Denver, Colorado; Memorial Sloan Kettering Cancer Center- Bergen in Montvale, New jersey; and 16 other sites."

Answered by AI
~59 spots leftby Apr 2025