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Evaluation of in vitro functional response profiling for precision medicine approaches in lymphomas and chronic lymphoproliferative syndromes

Not Applicable
Conditions
ymphomas and chronic lymphoproliferative syndromes
Cancer
Registration Number
ISRCTN63434223
Lead Sponsor
CellPly.S.r.l.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
500
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 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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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