Phase III Copanlisib in Rituximab-refractory iNHL

NCT ID: NCT02369016

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-22
• Study Completion Date: 2022-10-26

Brief Summary

To assess the safety of copanlisib.

Conditions

Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Copanlisib (BAY 80-6946)

patients with rituximab-refractory iNHL

Group Type: EXPERIMENTAL

Copanlisib (BAY 80-6946)

Intervention Type: DRUG

60 mg of experimental drug in solution administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle

Interventions

Copanlisib (BAY 80-6946)

60 mg of experimental drug in solution administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Jaú, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, , Brazil

Plovdiv, , Bulgaria

Athens, , Greece

Bologna, Emilia-Romagna, Italy

Genoa, Liguria, Italy

Gdynia, , Poland

Kazan', , Russia

Kemerovo, , Russia

Moscow, , Russia

Omsk, , Russia

Penza, , Russia

Johannesburg, Gauteng, South Africa

Seoul, Seoul Teugbyeolsi, South Korea

Jeollabuk-do, , South Korea

Jeollanam-do, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Taipei, , Taiwan

Istanbul, , Turkey (Türkiye)

Countries

Brazil; Bulgaria; Greece; Italy; Poland; Russia; South Africa; South Korea; Taiwan; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-000925-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17322

Identifier Type: -

Identifier Source: org_study_id