Recruiting NCT06357754
Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Idecabtagene vicleucel, Lisocabtagene maraleucel.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia, Multiple Myeloma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Japan, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protocol for Transgene Assay Service
Overview
The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.
Interventions
- Biological Idecabtagene vicleucel
As per product label - Biological Lisocabtagene maraleucel
As per product label
Primary outcome measures
- Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results [Time frame: Baseline]
- Participant insertion site analysis (ISA) testing results [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
- Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
Exclusion criteria
- Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.
- Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Local Institution - 0016 — Portland
- Ut Southwestern — Dallas
- Huntsman Cancer Institute at the University of Utah — Salt Lake City
- Local Institution - 0004 — Madison
Japan · 2 centers
- Toyokawa City Hospital — Toyokawa
- Local Institution - 0003 — Kumamoto
Germany · 1 center
- Universitaetsklinikum Essen (AoR) — Essen
Switzerland · 1 center
- Kantonsspital Aarau — Aarau
Identifiers
NCT: NCT06357754 · CA082-085