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Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.

NCT02391116•Bayer

View on ClinicalTrials.gov

Summary

To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
•Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
•Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
•Patients must have measurable disease.

Exclusion Criteria

•A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
•Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
•Adequate bone marrow, liver and renal function.
•Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
•Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
•Current central nervous system (CNS) involvement by lymphoma.
•Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
•Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
•Type I or II diabetes mellitus with HbA1c \> 8.5% at Screening.
+2 more criteria

Locations (32)

Kingswood, New South Wales, Australia

Ballarat, Victoria, Australia

Prahran, Victoria, Australia

Box Hill, Australia

Wilrijk, Antwerpen, Belgium

Bruxelles - Brussel, Belgium

Edegem, Belgium

Ghent, Belgium

Leuven, Belgium

St. John's, Newfoundland and Labrador, Canada

Key Dates

Start Date

May 8, 2015

Primary Completion Date

July 5, 2016

Completion Date

January 19, 2018

Last Updated

January 4, 2019

Enrollment

ACTUAL participants

Conditions

Diffuse, Large B-Cell, Lymphoma

Interventions

Copanlisib (Aliqopa, BAY80-6946)

DRUG

A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

NCT04236141

Diffuse, Large B-Cell, Lymphoma

View study

TERMINATEDPHASE2

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

NCT02374424

Diffuse, Large B-Cell, Lymphoma

View study

COMPLETEDPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients