Lymphoma EARLY Clinical Phases
CALYM has an extensive experience in designing and conducting lymphoma EARLY phase clinical studies: first-in-man, first-in-lymphoma, first combo studies.
40+ lymphoma Phase I/IIa trials were successfully designed and performed so far by our dedicated EARLY clinical teams and LYSA-LYSARC platform.
Integrated Expertise for Better Outcomes
EARLY, the LYSA-LYSARC lymphoma early phase clinical research platform benefits from the synergistic combination of:
- the outstanding scientific and therapeutic expertise of internationally renowned lymphoma specialists from the LYSA cooperative group
- the capacity and operational means of LYSARC, the largest European academicorganization devoted to clinical research operations in the lymphoma field.
LYSARC, the operational arm of LYSA, has been created to implement and run all the projects that have been previously assessed by LYSA’s Scientific Board and approved by its Board of Directors. This systematic selection process guarantees the scientific interest for the research program and efficient projects start-up.
Faster Patient Enrollment
- Network of selected LYSA sites
- Clinical trial centers with a large panel of skills
Devoted pharmacists, practitioners, CRAs, clinical trial nurses, 24/24 pharmacokinetics, imaging transfer software…
- The ClinTrial Refer LYSA App: a tool to accelerate patient enrollment
ClinTrial Refer LYSA aims at accelerating patients’ recruitment in LYSA clinical studies conducted in LYSA centers in France and abroad. This new tool provides physicians, real-time information on each on-going LYSA trial, facilitating recruitment of the patients they see during their consultations. ClinTrialRefer LYSA, available on iOS or Android store, is completely anonymous and does not store confidential data.
Full Scope of Clinical Research Operations and Skills to Conduct Early Lymphoma Studies
EARLY phase clinical research operations are conducted by LYSARC, usually sponsor of the trials it conducts: - Devoted staff, all lymphoma specialists with a track record in early phase clinical research - Fast implementation of clinical trials: usually less than 6 months between the collaboration agreement and first patient in (accelerated by the routine use of electronic signature) - High quality standards: regular industry audits, low incidence of non-compliance, corrective and preventive actions plan respected - High ethical and safety standards: compliance with patient safety rules and requirements of international regulatory guidelines - Dose escalation committee(standard operating procedure)
Identification of Early Pharmacodynamic Signs of Activity
Our teams aim at accelerating translational research through the identification of early signs of pharmacological activity during phase I/IIa clinical studies:
- Pharmacodynamic biomarkers
- Immunomonitoring platform (multicolor flow cytometry)
- Kinase activation, telomere and telomerase activity
- Co-stimulation of T-cells and phosphatidyl-inositol 3’-kinase (PI-3K) signaling pathway
- Correlation between transcriptome / genome and PET scan imaging
- Functional studies of patients treated with innovative therapeutic approaches
- PK-PD of therapeutic and adverse effects activity of monoclonal antibodies