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Phase III Copanlisib in Rituximab-refractory iNHL (CHRONOS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02369016
Recruitment Status : Active, not recruiting
First Posted : February 23, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To assess the safety of copanlisib

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Copanlisib (BAY 80-6946) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 : September 22, 2015
Estimated Primary Completion Date : November 7, 2018
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events [ Time Frame: Up to 3 years ]
  2. Number of patients with serious adverse events [ Time Frame: Up to 3 years ]
  3. Number of patients with abnormal lab parameters [ Time Frame: Up to 3 years ]
  4. Number of patients with abnormal vital signs [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369016


Locations
Brazil
Jaú, Sao Paulo, Brazil, 17210-120
São Paulo, Sao Paulo, Brazil, 08270-070
Sao Paulo, Brazil
Bulgaria
Plovdiv, Bulgaria, 4002
China, Heilongjiang
Harbin, Heilongjiang, China
France
France, France
Greece
Athens, Greece, 11526
Italy
Bologna, Emilia-Romagna, Italy, 40138
Genova, Liguria, Italy, 16132
Korea, Republic of
Jeollabuk-do, Korea, Republic of, 561-712
Jeollanam-do, Korea, Republic of, 519-763
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 120-752
Poland
Gdynia, Poland, 81-519
Portugal
Almada, Portugal, 2801-951
Russian Federation
Kazan, Russian Federation, 420029
Kemerovo, Russian Federation, 650066
Moscow, Russian Federation, 123182
Omsk, Russian Federation, 644013
Penza, Russian Federation, 440071
South Africa
Johannesburg, Gauteng, South Africa, 2013
Taiwan
Taipei, Taiwan, 10002
Turkey
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02369016     History of Changes
Other Study ID Numbers: 17322
2014-000925-19 ( EudraCT Number )
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
indolent Non-Hodgkin lymphoma
rituximab-refractory

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents