Study for patients with mantle cell lymphoma (one type of lymphomas = lymph node cancer), aimed to answer the question if patients who relapse after previous therapy with Bruton tyrosine kinase inhibitor (type of biologivcal treatment) will be beneficiary adding of polatuzumab vedotin (new type of biological treatment) to commonly used treatment with bendamustine and rituxima (combination of chemotherpay and biological treatment)
- Conditions
- Mantle cell lymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-000468-32-CZ
- Lead Sponsor
- Kooperativní lymfomová skupina, z.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
Patients must meet the following criteria for study entry:
•Signed written Informed Consent Form
•Adult patients with relapsed or refractory MCL after failure of BTK inhibitor-containing therapy (e.g. ibrutinib, acalabrutinib, zanubrutinib)
•Patients previously treated with bendamustine are eligible for the study treatment, in the case they had achieved objective response (CR or PR) and the last dose of bendamustine was administered = 1 year before the estimated study treatment initiation date (C1D1)
•Tumor tissue at the lymphoma relapse after failure of BTK inhibitor. In case that a re-biopsy is not possible (e.g. urgent need to start study treatment), archival tissue blocks may be used to confirm the diagnosis
•Bone marrow examination by standard trephine biopsy including flow cytometry analysis within 8 weeks before study entry
•Age 18-80 years at the time of signing Informed Consent Form
•ECOG Performance Status of 0, 1, or 2
•Life expectancy = 2 months
•Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by MCL per the investigator), defined as follows:
– Hemoglobin = 80g/L
- Leukocyte count = 3,000/uL
– ANC = 1,500/µL
– Platelet count = 75,000/µL
Enrollment of patients with lower counts is possible only after consulting the medical monitor.
•Adequate cardiac functions according to echocardiography (ECHO) within 6 months before study entry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
•Prior organ transplantation
•Current Grade = 2 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
•History of other malignancy that could affect compliance with the protocol or interpretation of results
Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible
Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for = 2 years prior to enrollment are eligible
Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage
1 or 2) with no requirement for therapy at any time prior to study are eligible.
•Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results.
•Recent major surgery (e.g. within 4 weeks prior to the start of Cycle 1), other than for diagnosis
•Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1.
•Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
•Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
•Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
INR > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation aPTT > 1.5 x ULN in the absence of a lupus anticoagulant
•Serum AST and ALT > 3 x ULN
•Total bilirubin > 1,5 x ULN
Patients with documented Gilbert disease may be enrolled if total bilirubin is < 3.0 x ULN.
•Serum creatinine clearance < 40 mL/min (using Cockcroft-Gault formula or creatinine levels assessed directly from the collected urine)
•Patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
•Positive test results for chronic hepatitis B infection defined as positive hepatitis B surface antigen (HBsAg) serology
•Patients with occult or prior hepatitis B infection defined as positive total hepatitis B core antibody and negative HBsAg may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo regular DNA testing and appropriate antiviral therapy as indicated.
•Positive test results for hepatitis C virus (HCV) antibody serology testing
Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
•Known history of HIV seropositive status
•Patients with a history of progressive multifocal leukoencephalopathy
•Pregnancy or lactation or intending to become pregnant during study
•CNS lymphoma
In patients with clinical signs attributable to CNS lymphoma, CT scan (MRI also acceptable) of the head and examination of cerebrospinal fluid will be required prior to study treatment initiation
• Vaccination with live or attenuated vaccines 30 days before initiation of study treatment
• Known hypersensitivity to Polatuzumab Vedotin, Rituximab or bendamustine, or their excipients
• Clinically significant immunosuppression
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method