Trial Condition(s):

Lymphoma, Non-Hodgkin

Phase III copanlisib in rituximab-refractory iNHL (CHRONOS-2)

Bayer Identifier:

17322

ClinicalTrials.gov Identifier:

NCT02369016

EudraCT Number:

2014-000925-19

Study Completed

Trial Purpose

To assess the safety of copanlisib.

Inclusion Criteria
- Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
-- Follicular lymphoma (FL) grade 1-2-3a.
-- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10*9/L at the time of diagnosis and at study entry.
-- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
-- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal).
- Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.
- Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
- Patients must be refractory to the last rituximab-based treatment, defined as no response or response lasting < 6 months after completion of treatment. Time interval to assess refractoriness will be calculated between the end date (last day) of the last rituximab-containing regimen and the day of diagnosis confirmation of the subsequent relapse.
- Patients must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: 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 (ULN)and positive immunofixation test.
- ECOG performance status ≤ 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria
- Histologically confirmed diagnosis of FL grade 3b.
- Chronic lymphocytic leukemia (CLL).
- Transformed disease (assessed by investigator):
-- histological confirmation of transformation, or
-- clinical and laboratory signs: rapid disease progression, high standardized uptake value (SUV) (> 12) by positron emission tomography (PET) at baseline if PET scans are performed (optional).
- Bulky disease - Lymph nodes or tumor mass (except spleen) >= 7cm LD (longest diameter)
- Known lymphomatous involvement of the central nervous system.
- Uncontrolled arterial hypertension despite optimal medical management (per investigator’s assessment).
- Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
- Known history of human immunodeficiency virus (HIV) infection.
- Active clinically serious infections > CTCAE Grade 2
- Active Hepatitis B or hepatitis C
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
- History of having received an allogeneic bone marrow or organ transplant
- Positive cytomegalovirus (CMV) PCR test at baseline
- Pregnant or breast-feeding patients

Trial Summary

Enrollment Goal
25
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Johannesburg, South Africa, 2013

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16132

Status
Completed
 
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Investigative Site

Istanbul, Turkey, 34093

Status
Completed
 
Locations

Investigative Site

Omsk, Russia, 644013

Status
Completed
 
Locations

Investigative Site

Penza, Russia, 440071

Status
Completed
 
Locations

Investigative Site

Kemerovo, Russia, 650066

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 100

Status
Completed
 
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Investigative Site

Gdynia, Poland, 81-519

Status
Completed
 
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Investigative Site

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil

Status
Terminated
 
Locations

Investigative Site

Jaú, Brazil, 17210-120

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Jeollabuk-do, South Korea, 561-712

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03722

Status
Completed
 
Locations

Investigative Site

Athens, Greece, 115 26

Status
Completed
 
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Investigative Site

Moscow, Russia, 123182

Status
Completed
 
Locations

Investigative Site

Kazan, Russia, 420029

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 08270-120

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Jeollanam-do, South Korea, 58128

Status
Completed
 

Trial Design