Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:January 6, 2016
End Date:December 31, 2024
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

Use our guide to learn which trials are right for you!

A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

The purpose of this study is to assess whether copanlisib in combination with standard
immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in
combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and
prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination
with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have
received at least one, but at most three, lines of treatment, including rituximab-based
immunochemotherapy and alkylating agents.

Patients should be in need of and fit for immunochemotherapy and should not be resistant to
rituximab (resistance defined as lack of response or progression within 6 months of the last
date of rituximab administration, including rituximab maintenance). This study will be
composed of two parts: Safety run-in and phase III part.

The purpose of the safety run-in part of this study is to assess whether the drug being
tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe
and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to
tolerate the study treatment combination. In addition to finding a safe and tolerable dose
level for the phase III part of the study, efficacy will also be evaluated for patients that
stay on the study treatment during the safety run-in. The phase III part of the study started
with the determined recommended dose of copanlisib of 60 mg in combination with R-B.

A maximum of 24 patients will take part in the safety run-in part of this study. In the phase
III part approximately 520 patients will be randomly assigned to blinded treatment arms of
copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP.

Inclusion Criteria:

- Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with
histological subtype limited to:

- Follicular lymphoma G1-2-3a

- Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/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) or progressed after at least one but at most three
prior lines of therapy, including rituximab-based immunochemotherapy and alkylating
agents (if given concomitantly is considered one line of therapy). A previous regimen
is defined as one of the following: at least 2 months of single-agent therapy (less
than 2 months of therapy with single agent rituximab can be considered a previous
regimen in the case the patient responded to it); at least 2 consecutive cycles of
polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to
other PI3K Inhibitors (except copanlisib) is acceptable provided there is no
resistance (resistance defined as no response (response defined as partial response
[PR] or complete response [CR]) at any time during therapy, or progressive disease
(PD) after any response (PR/CR) or after stable disease within 6 months from the end
of the therapy with a PI3K inhibitor.

- Non-WM patients must have at least one bi-dimensionally measurable lesion (that has
not been previously irradiated) according to the Lugano Classification. For patients
with splenic MZL 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 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 at Screening

- Adequate baseline laboratory values as assessed within 7 days before starting study
treatment.

- Left ventricular ejection fraction ≥ 50%

Exclusion Criteria

- Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed
disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of
transformed disease, a fresh biopsy is recommended.

- Rituximab resistance at any line of therapy (resistance defined as lack of response,
or progression within 6 months of the last date of rituximab administration, including
rituximab maintenance).

- HbA1c > 8.5% at Screening

- History or concurrent condition of interstitial lung disease and/or severely impaired
lung function (as judged by the investigator)

- Known lymphomatous involvement of the central nervous system

- Known history of human immunodeficiency virus (HIV) infection

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

- Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will
not be eligible.CMV PCR test is considered positive if, the result can be interpreted
as a CMV viremia according to local standard of care.

- Uncontrolled hypertension despite optimal medical management (per investigator´s
assessment)

- Congestive heart failure > New York Heart Association (NYHA) class 2
We found this trial at
49
sites
2776 Enterprise Road
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Anchorage, Alaska 99503
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
?
mi
from
Commack, NY
Click here to add this to my saved trials
370 Victoria Street
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
235 North Belle Mead Avenue
East Setauket, New York 11733
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
?
mi
from
Greenville, NC
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77203
?
mi
from
Houston, TX
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
3855 Health Sciences Drive
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Laredo, Texas 78041
?
mi
from
Laredo, TX
Click here to add this to my saved trials
Lawton, Oklahoma 73505
?
mi
from
Lawton, OK
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Lubbock, Texas 79415
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
480 Red Hill Road
Middletown, New Jersey 07748
?
mi
from
Middletown, NJ
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Montvale, NJ
Click here to add this to my saved trials
100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Nyack, NY
Click here to add this to my saved trials
Olympia, Washington 98502
?
mi
from
Olympia, WA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
Spokane, Washington 99208
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Thomasville, Georgia 31792
?
mi
from
Thomasville, GA
Click here to add this to my saved trials
401 9th Avenue Northwest
Watertown, South Dakota 57201
?
mi
from
Watertown, SD
Click here to add this to my saved trials
West Covina, California 91790
?
mi
from
West Covina, CA
Click here to add this to my saved trials
?
mi
from
Westwood, NJ
Click here to add this to my saved trials