Supporting a Phase II Leukemia Cell Therapy Study with Clinion EDC
Overview
A Phase II oncology study evaluating cell therapy in patients with relapsed or refractory CD19-positive B-cell malignancies required a structured digital workflow for safety, efficacy, infusion, and follow-up data capture. The public registry describes the study as an open-label, non-randomized cell and gene therapy trial involving patients with acute lymphoblastic leukemia and non-Hodgkin lymphoma.
Because the study involved a specialized cell therapy pathway, the study team needed a reliable way to capture eligibility details, treatment information, adverse events, disease response, and long-term follow-up data across participating hematology and oncology centers.
Clinion EDC was configured as the central data capture platform for the study. It helped the study team standardize protocol-aligned eCRFs, capture high-complexity safety and efficacy data, manage data review, and maintain centralized visibility across the study workflow.
Study Snapshot
Industry
Biotech
Client
Cell-therapy biotech sponsor
Study Type
Interventional
Therapeutic Area
Oncology
Study Phase
Phase II
Study Design
Non-randomized, open-label and gene therapy study
Randomization
Not applicable
Region
India
Site Count
5 sites, per project input
Submission
DCGI (India)
Study Duration
28 months as per project input
Products Provided
Challenges
Capturing High-Complexity Cell Therapy Data Across Oncology Centers
The trial required teams to capture immediate safety events after infusion as well as longer-term response and survival outcomes over follow-up. The challenge was keeping this high-risk, high-detail data structured, traceable, and consistent across participating oncology centers.
01
Tracking Safety Events After Cell Therapy Infusion
Cell therapy patients can experience important safety events after infusion, including adverse events, cytokine release syndrome, neurotoxicity, and treatment-related complications. The study team needed a clear way to capture these events quickly, accurately, and in the right category for review.
02
Following Patient Response Over Time
Beyond early safety monitoring, the trial also needed to track how patients responded over time, including disease response, minimal residual disease, progression-free survival, overall survival, and duration of response. This required a data capture setup that could support follow-up beyond the initial treatment window.
03
Aligning Data Capture Across Specialist Oncology Sites
The study involved specialist hematology and oncology centers across multiple Indian locations. Each site needed to capture screening, eligibility, infusion, safety, and follow-up data in the same structure, so the sponsor could review the study without site-to-site variation creating extra work.
Solutions
A Structured Clinion EDC Workflow for Safety and Long-Term Outcomes Data
Clinion EDC was configured to support this trial’s demands: intensive near-term safety monitoring and long-term response tracking across a multi-site network in India.
Outcomes
Core Results
Clinion EDC gave the sponsor a controlled foundation for managing complex cell-therapy trial data from early safety review through long-term study follow-up.
Safety Data Traceability
Structured eCRFs helped capture key post-infusion safety events consistently.
Long-Term Follow-Up Continuity:
EDC workflows supported response and survival data capture over extended follow-up.
Multisite Data Consistency
A shared EDC environment helped sites capture trial data in the same structure.
Build Reliable Data Workflows with Clinion EDC
Cut your trial costs by 35% and accelerate your time-to-market by 30%
Compliance
Fully Compliant with Global Standards
