Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 3, 2015
End Date:August 28, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3

The purpose of this study is to evaluate whether copanlisib in combination with rituximab is
superior to placebo in combination with rituximab in prolonging progression free survival
(PFS) in patients with relapsed iNHL who have received one or more lines of treatment,
including rituximab and who either had a treatment-free interval of ≥ 12 months after
completion of the last rituximab-containing treatment, or who are unwilling to receive
chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or
residual toxicity.


Inclusion Criteria:

- Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20
positive patients, with histological subtype limited to:

- Follicular lymphoma(FL) grade1-2-3a

- Small lymphocytic lymphoma(SLL) with absolute lymphocyte count <5x10*9/L at study
entry

- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

- Patients must have relapsed (recurrence after complete response or presented
progression after partial response) after last rituximab-containing therapy (other
previous treatment lines after rituximab are allowed). A previous regimen is defined
as one of the following: at least 2 months of single-agent therapy (less than 2 months
of therapy is allowed for patients who responded to single-agent rituximab); at least
2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy.
Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no
resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib
are eligible.

- Non-WM must have at least one bi-dimensionally measurable lesion (which has not been
previously irradiated) according to the Lugano Classification. For patients with
splenic MZL (Marginal-zone lymphoma) this requirement may be restricted to
splenomegaly alone since that is usually the only manifestation of measurable disease.

- 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 .

- Male or female patients ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Life expectancy of at least 3 months

- Availability of fresh tumor tissue and/or archival tumor tissue (obtained within 5
years of the consent date) at Screening

- Adequate baseline laboratory values collected no more than 7 days before starting
study treatment

- Left ventricular ejection fraction ≥ 45%

- Patients must either:

- have had a progression-free and treatment-free interval of at least 12 months
after completion of the last rituximab-containing treatment OR

- be considered unfit to receive chemotherapy on reason of age, concomitant
morbidities, and/or residual toxicity from previous treatments, or unwillingness
to receive chemotherapy. These patients must also have had a progression-free and
treatment-free interval of at least 6 months after completion of the last
rituximab-containing treatment. Patients in whom chemotherapy is contraindicated
are defined by one of the following features:

- Age ≥ 80 years

- Age < 80 years and at least 1 of the following conditions:

- at least 3 grade 3 CIRS-G comorbidities OR

- at least 1 grade 4 CIRS-G comorbidity (if compatible to participation
in the study).

Exclusion Criteria:

- Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed
disease, or chronic lymphocytic leukemia

- Progression free interval or treatment free interval of less than 12 months since the
last rituximab containing treatment (including rituximab maintenance). For patients
considered unwilling/unfit to receive chemotherapy : progression free interval or
treatment free interval of less than 6 months since the last rituximab containing
treatment (including rituximab maintenance), as assessed by the investigator

- History or concurrent condition of interstitial lung disease of any severity and/or
severely impaired lung function

- Known lymphomatous involvement of the central nervous system

- Patients with HbA1c > 8.5% at Screening

- Known history of human immunodeficiency virus (HIV) infection

- Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be
eligible if they are negative for HBV-DNA, these patients should receive prophylactic
antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they
are negative for HCV-RNA

- Documented evidence of resistance to prior treatment with idelalisib or other PI3K
inhibitors.

- Prior treatment with copanlisib

- Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will
not be eligible
We found this trial at
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