Phase 3
N=25
Phase III Copanlisib in Rituximab-refractory iNHL
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT02369016 ↗Enrolled (actual)
25
Serious AEs
41.1%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAE)s — 17; 7; 7; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Copanlisib (BAY 80-6946) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAE)s |
17; 7; 7; 24 | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)s |
6; 1; 5; 11 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Parameters |
9; 1; 3; 12; 6; 0 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs |
2; 0; 1; 3; 1; 0 | — |
Summary
To assess the safety of copanlisib.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02369016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.