Marginal Zone Lymphoma MedDRA version: 21.0 Level: PT Classification code 10062113 Term: Splenic marginal zone lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10076596 Term: Marginal zone lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Copanlisib
Product Code: BAY84-1236
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: COPANLISIB
CAS Number: 1032568-63-0
Current Sponsor code: BAY 84-1236
Sponsors
University Hospital Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have a proven pathological diagnosis of MZL, diagnosed by a reference pathology center. Patients must meet the following inclusion criteria to be eligible for participation in this study: – Confirmed CD20 positive de novo or relapsed MALT Lymphoma in need of treatment following or being not eligible for local therapy (including surgery, radiotherapy and antibiotics e.g. for H. pylori-positive gastric lymphoma arisen at any extranodal site) OR – Confirmed CD20 positive de novo or relapsed splenic MZL in need of treatment following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) OR – Confirmed CD20 positive de novo or relapsed nodal MZL in need of treatment following or not being eligible for local therapy (radiotherapy) For nodal MZL and extragastric MALT lymphoma: – At least one bi-dimensionally measurable lesion (= 1.5 cm in its largest dimension by CT scan or MRI). Please refer to Appendix C. For SMZL: For splenic MZL, an enlarged spleen on CT scan and lymphoma cell infiltration has to be seen in bone marrow and/or peripheral blood. Please refer also to Appendix E. At least one of the following criteria must be met: – Bulky progressive or painful splenomegaly – one of the following symptomatic/progressive cytopenias : Hb =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrolment: – ECOG performance status = 2 – History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for =1 year prior to study enrolment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for =3 years. – Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma. – Ongoing immunosuppressive therapy including corticosteroids (expection New York Heart Association (NYHA) class 2 – Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). – Myocardial infarction less than 6 months before start of test drug – Uncontrolled arterial hypertension despite optimal medical management – HbA1c> 8.5% – Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results. – History of anaphylaxis in association with previous administration of monoclonal antibodies. – Vaccination with a live vaccine within 28 days prior to start of therapy – Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication – Non-healing wound, ulcer, or bone fracture – History or concurrent interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to test the efficacy and toxicity of the treatment of Copanlisib/Rituximab in patients with MZL in need of treatment, who have failed or are not eligible for local therapy or relapsed after local or systemic therapy. For efficacy the rate of complete remissions (according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for non-gastric extranodal, nodal and splenic MZL) after induction therapy will be primarily analysed [4-7]. For toxicity treatment associated adverse events, quality of life and cumulative incidence of secondary malignancies will be documented. ;Secondary Objective: •Response rate (CR, PR, CR or PR) •Best response •Time to best response •Time to first response •Progression free survival (PFS) •Time to treatment failure (TTF) •Duration of Response (DR) •Cause specific survival (CSS) •Overall survival (OS) •Quality of life during induction and maintenance therapy ;Primary end point(s): Primary Endpoint: • CR rate (CRR) 12 months after start of treatment ;Timepoint(s) of evaluation of this end point: Determined 12 months after start of induction therapy, i.e. month 6 of maintenance | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints(s): • Response rate (CR, PR, CR or PR) • Best response • Time to best response • Time to first response • Progression free survival (PFS) • Time to treatment failure (TTF) • Duration of Response (DR) • Cause specific survival (CSS) • Overall survival (OS) • Quality of life during induction and maintenance therapy;Timepoint(s) of evaluation of this end point: 12 month after start of induction therapy, i.e. month 6 of maintenance and after end of study | — |
Countries
Austria, Germany
Contacts
Public ContactProf. Dr. med. Christian Buske
University Hospital Ulm
Outcome results
None listed