Phase III Copanlisib in Rituximab-refractory iNHL

NCT02369016 | Completed Phase 3 Results DMC

• 2 other identifiers: 173222014-000925-19
• Study Type: interventional
• Target: 25
• Locations: 10 countries
• Sites: 21

Brief Summary

To assess the safety of copanlisib.

Conditions

Lymphoma, Non-Hodgkin

Keywords

indolent Non-Hodgkin lymphoma; rituximab-refractory

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAE)s

  Adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)

  up to 7 years

• Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)s

  Serious adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)

  up to 7 years

• Number of Participants With Abnormal Laboratory Parameters

  \- Above threshold of 10% and reported as TEAEs - any event (Grade 1-4)

  up to 7 years

• Number of Participants With Abnormal Vital Signs

  \- Reported as TEAEs - worst CTCAE grade total -

  up to 7 years

Study Arms (1)

Copanlisib (BAY 80-6946)

EXPERIMENTAL

patients with rituximab-refractory iNHL

Drug: Copanlisib (BAY 80-6946)

Interventions

Copanlisib (BAY 80-6946) DRUG

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

Copanlisib (BAY 80-6946)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (21)

Unknown Facility

Jaú, São Paulo, 17210-120, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 08270-070, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Plovdiv, 4000, Bulgaria

Location

Unknown Facility

Athens, 115 26, Greece

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Genoa, Liguria, 16132, Italy

Location

Unknown Facility

Gdynia, 81-519, Poland

Location

Unknown Facility

Kazan', 420029, Russia

Location

Unknown Facility

Kemerovo, 650066, Russia

Location

Unknown Facility

Moscow, 123182, Russia

Location

Unknown Facility

Omsk, 644013, Russia

Location

Unknown Facility

Penza, 440071, Russia

Location

Unknown Facility

Johannesburg, Gauteng, 2013, South Africa

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Unknown Facility

Jeollabuk-do, 561-712, South Korea

Location

Unknown Facility

Jeollanam-do, 58128, South Korea

Location

Unknown Facility

Seoul, 05505, South Korea

Location

Unknown Facility

Seoul, 3722, South Korea

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

copanlisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 23, 2015
• Study Start: September 22, 2015
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); GR (1); PL (1); RU (5); BR (3); KR (5); TU (1); BU (1); TW (1); ZA (1)