Lymphomas and chronic lymphoproliferative syndromes Cancer
Conditions
Interventions
The study is focused on in-vitro studies of drug response determined by evaluating the functional response of living cells extracted from patient samples, exposed in-vitro to multiple drug-based treat
Sponsors
CellPly.S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for Arm A (chronic lymphocytic leukemia): 1. Confirmed diagnosis of CLL 2. Age greater than or equal to 18 years 3. Patient treatment-naïve or relapsed/refractory after previous therapy(ies) 4. Patient in “watch and wait” status or patient requiring drug-based treatment for CLL 5. Availability of clinical data (demographic data, medical history) 6. Patients must provide written informed consent Inclusion criteria for Arm B (lymphomas): 1. Histologically-confirmed diagnosis of Hodgkin Lymphoma (HL) or Non Hodgkin Lymphoma (NHL) 2. Age greater than or equal to 18 years 3. Patient requiring drug-based therapy for the treatment of HL or NHL 4. Patient requiring a nodal or extranodal biopsy before treatment (only patients with availability biopsy performed during normal clinical practice before treatment will be enrolled) 5. Availability of clinical data (demographic data, medical history) 6. Patients must provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for Arm A and Arm B: 1. Current therapy with anti-neoplastic or investigational agents 2. Known human immunodeficiency virus (HIV) positivity 3. Known hepatitis B surface antigen-positivity or known or suspected active hepatitis C infection 4. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity determined as the proportion of the responders to the treatment that are correctly identified as such by Sponsor’s test 2. Specificity determined as the proportion of the non-responders to the treatment that are correctly identified as such by Sponsor’s test 3. Positive predictive value (PPV) determined as the proportion of the responders to the treatment among all the patients defined as responders by the Sponsor’s test 4. Negative predictive value (NPV) determined as the proportion of the non-responders to the treatment among all the patients defined as non-responders by the Sponsor’s test 5. Accuracy determined as the proportion of patients (both responders and non-responders) whose outcomes correctly predicted by the test among all the patients tested [Timepoint: each restaging event] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Response Rate (ORR) in patient populations identified by the test defined as the proportion of patients with complete remission or partial remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007; Hallek et al., 2008). [Timepoints: each restaging event] 2. Progression-Free Survival (PFS) in patient populations identified by the test defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first [Timepoint: 1 year] 3. Duration of response in patient populations identified by the test defined as the time from start of the first documentation of objective tumor response (complete response, CR or partial response, PR) to the first documentation of objective tumor progression or to death due to CLL/lymphoma, whichever comes first. [Timepoint: every 3 months for the first 2 years post treatment] 4. Clinical response, a classification of patients according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007; Hallek et al., 2008) [Timepoints: each restaging event] | — |
Countries
Italy
Contacts
Public ContactLaura Rocchi
Outcome results
None listed