CHRONOS-2: Phase III Copanlisib in Rituximab-refractory iNHL

Sponsor
Bayer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02369016
Collaborator
(none)
25
21
1
86.3
1.2
0

Study Details

Study Description

Brief Summary

To assess the safety of copanlisib.

Condition or Disease Intervention/Treatment Phase
  • Drug: Copanlisib (BAY 80-6946)
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Phase III Study of Copanlisib Versus Placebo in Patients With Rituximab-refractory Indolent Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-2
Actual Study Start Date :
Sep 22, 2015
Anticipated Primary Completion Date :
Nov 23, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Copanlisib (BAY 80-6946)

patients with rituximab-refractory iNHL

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with treatment-emergent adverse events [Up to 3 years]

  2. Number of patients with serious adverse events [Up to 3 years]

  3. Number of patients with abnormal lab parameters [Up to 3 years]

  4. Number of patients with abnormal vital signs [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jaú Sao Paulo Brazil 17210-120
2 São Paulo Sao Paulo Brazil 08270-120
3 Sao Paulo Brazil
4 Plovdiv Bulgaria 4002
5 Athens Greece 115 26
6 Bologna Emilia-Romagna Italy 40138
7 Genova Liguria Italy 16132
8 Seoul Seoul Teugbyeolsi Korea, Republic of 03080
9 Jeollabuk-do Korea, Republic of 561-712
10 Jeollanam-do Korea, Republic of 58128
11 Seoul Korea, Republic of 03722
12 Seoul Korea, Republic of 05505
13 Gdynia Poland 81-519
14 Kazan Russian Federation 420029
15 Kemerovo Russian Federation 650066
16 Moscow Russian Federation 123182
17 Omsk Russian Federation 644013
18 Penza Russian Federation 440071
19 Johannesburg Gauteng South Africa 2013
20 Taipei Taiwan 100
21 Istanbul Turkey 34093

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02369016
Other Study ID Numbers:
  • 17322
  • 2014-000925-19
First Posted:
Feb 23, 2015
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022