Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2015-001088-38-IT
EUCTR2015-001088-38-ITActive, not recruitingPhase 1

A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combinatione with standard immunochemiotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL) - CHRONOS-4 - Phase III study of copanlisib with standard immunochemotherapy in relapsed iNH

BAYER HEALTHCARE AG0 sites700 target enrollmentStarted: February 23, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
700
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Main criteria for inclusion:- Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:o Follicular lymphoma (FL) G1, G2, or G3ao Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5x109/L at the time of diagnosis and at study entryo Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM)o Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)- Patients must have relapsed after at least 1 prior line of therapy, including rituximab and alkylating agents. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K inhibitors is acceptable provided there is no resistance (treatment stopped for other reasons than progressive disease).- Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification.- Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level = 2 x upper limit of normal.- Male or female patients = 18 years of age.- Eastern Cooperative Oncology Group (ECOG) performance status = 2.- Life expectancy of at least 3 months.- Availability of fresh tumor tissue and/or archival tumor tissue at Screening.- Adequate baseline laboratory values as assessed within 7 days before starting study treatment.- Left ventricular ejection fraction = 50%.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 1
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 600
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

  • •Main criteria for exclusion:- Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3bor transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.- Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen).- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening.- History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator).- Known lymphomatous involvement of the central nervous system.- Human immunodeficiency virus (HIV) infection.- Hepatitis B (HBV) and C (HCV) infection. Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative and Anti-HBs positive) will be eligible.- Congestive heart failure > New York Heart Association (NYHA) class 2.- Uncontrolled hypertension (systolic blood pressure > 150 mmHg ordiastolic pressure > 90 mmHg despite optimal medical management).

Investigators

Similar Trials

Active, not recruiting
Phase 1
A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.Patients with relapsed indolent non-Hodgkin's lymphomaMedDRA version: 20.0Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2015-001088-38-CZBayer AG520
Active, not recruiting
Phase 1
A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.Patients with relapsed indolent non-Hodgkin's lymphomaMedDRA version: 21.1 Level: PT Classification code 10029600 Term: Non-Hodgkin's lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2015-001088-38-SKBayer AG520
Active, not recruiting
Phase 1
A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.Patients with relapsed indolent non-Hodgkin's lymphomaMedDRA version: 20.0Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2015-001088-38-GBBayer AG520
Active, not recruiting
Phase 1
A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.Patients with relapsed indolent non-Hodgkin's lymphomaMedDRA version: 23.0Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2015-001088-38-DEBayer AG520
Active, not recruiting
Phase 1
A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.Patients with relapsed indolent non-Hodgkin's lymphomaMedDRA version: 23.0Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2015-001088-38-PLBayer AG520