Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
REMOVE
1 other identifier
interventional
136
1 country
6
Brief Summary
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2024
CompletedFirst Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedJanuary 23, 2025
January 1, 2025
1.8 years
January 10, 2025
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
depletion of EpCAM-positive tumor cells
Tumor cell count (Depletion) measured with Immun-histo chemistry staining and tumor cell counting in a Neubauer Chamber * a depletion to ≤10 cells per 100 mL EC, OR * if \<100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 103 in the EC (total) as compared to collected intraoperative blood (total), OR * if ≥100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 5x103 in the EC (total) as compared to collected intraoperative blood (total), in at least 95% of subjects after one IBS/LDF cycle using the Catuvab device. The primary endpoint will only be determined in subjects with EpCAM-positive tumor cells in salvaged blood and who receive retransfusion of the EC
during surgery only
Study Arms (1)
medical device validation
OTHERremoval of tumor cells of EpCAM positive tumors during surgery
Interventions
inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates
Eligibility Criteria
You may qualify if:
- Intraoperative blood salvage (IBS)-eligible according to the Investigator
- Patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being EpCAM-positive (\>92%) OR kidney carcinoma or liver carcinoma.
- For patients with cancer types with a high likelihood of being EpCAM-positive (\>92%): if a tumor tissue sample is available and has been EpCAM tested or EpCAM-testing can be done within 5 days of signing the informed consent form (ICF): results of EpCAM typing should be positive.
- For patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested EpCAM-positive prior to surgery.
- Scheduled for surgery to remove tumor.
- The Investigator expects that at least 400 mL full blood can be collected during the tumor surgery.
- An American Society of Anesthesiologists (ASA) Classification of ≤3.
You may not qualify if:
- Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
- Lymphocytopenia (count \<1.0 x 109 /L lymphocytes).
- Cancer different from indicated types, especially typically EpCAM-negative tumor types.
- Sepsis occurring during surgery.
- Cirrhosis of the liver with a Child-Pugh score of C.
- A thrombocyte count of \<30.000/µL.
- Allergies and/or contraindications against Catumaxomab or any of the components or ingredients used in the IBS procedure (e.g., leukocyte depletion filter \[LDF\], diluent, buffer solution or anticoagulants).
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Kliniken der Stadt Köln gGmbH
Cologne, North Rhine-Westphalia, 51109, Germany
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
Mainz, 55131, Germany
Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Mannheim, 68167, Germany
Klinikum Traunstein
Traunstein, 83278, Germany
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg
Würzburg, 97080, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Markus Heiss, MD
University Köln Merheim
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
January 23, 2025
Study Start
February 15, 2022
Primary Completion
November 25, 2023
Study Completion
April 14, 2024
Last Updated
January 23, 2025
Record last verified: 2025-01