A study evaluating the safety and efficacy of 19CP02 in subjects with non-Hodgkin lymphoma
- Conditions
- Relapsed/refractory B-cell non-Hodgkin lymphomaMedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-003272-13-NL
- Lead Sponsor
- CellPoint B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
1. Signed informed consent form
2. Age = 18 years
3. Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, or MCL
4. Relapsed or refractory disease
5. Measurable disease according to the Lugano classification
6. ECOG performance status of 0 or 1 (ECOG 2 is allowed if due to underlying disease)
7. Adequate bone marrow, renal, hepatic and pulmonary function
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 30
1. Primary CNS B-cell lymphoma, Burkitt lymphoma, or Richter’s transformation
2. Selected prior treatments as defined in the protocol
3. History of malignancy other than lymphoma (exceptions per protocol)
4. Active CNS involvement (with neurological changes) by disease under study
5. Infection with HIV, hepatitis B or hepatitis C virus
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