A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

Completed

Conditions studied: Transfusion Related Acute Lung Injury

In brief

This study is a prospective, non-randomized sequential cohort, open label, multi-center, non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The patient population will be hematology-oncology patients, including those undergoing hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions. For each participating center, the study will start with a brief pilot run-in period with a group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot run-in is to evaluate study logistics and data collection methods within each study center. Data from the pilot phase will be included in the data analysis for the treatment comparison. After the pilot run-in period, the study will be conducted in two sequential patient cohorts: 1) the Control cohort during which study patients will receive only conventional PCs, and 2) the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient enrollment at each Center will be monitored to target similar numbers of patients into the Control and Test Cohorts within each center. Centers may enroll Control and Test patients in ratios that vary from 2:1 to 1:2 due to institutional requirements to move rapidly to full INTERCEPT implementation, or due to availability issues with either Test or Control components. Within each Center, patient enrollment will be stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3) non-myeloablative conditioning, and (4) reduced intensity using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. Note time from last chemotherapy treatment to first study transfusion should be no more than 30 days. To ensure both Test and Control cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen strata, enrollment caps will be set for the Test cohorts, hence no Test patients will be enrolled to a stratum once the cap for the given stratum is met. Eligible patients will be enrolled in open Test strata sequentially as long as there is sufficient Test PC inventory available. Enrollment may be delayed for the Test cohort if sufficient inventory of Test PCs is not available.

Key facts

Study ID: NCT02549222
Run by: Cerus Corporation
People needed: 2291
Starts: 2015-12-01
Expected to finish: 2021-05-01
Last updated by the study team: 2022-02-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with a hematology-oncology disorder expected to require or requiring a transfusion of one or more PCs (time from last chemotherapy treatment to first study transfusion should be 30 days or less).
Written signed informed consent (unless exemption of individual consent is granted by the center's IRB).

You may not qualify if…

Assisted ventilation (administered by intubation or tight fitting mask with PEEP or CPAP ≥ 5 cm H2O) within 30 days prior to the first study PC transfusion. In the event that PEEP or CPAP values are unavailable for prior assisted ventilation events administered by intubation or tight fitting mask, they will be interpreted as meeting the exclusion criterion. For the purposes of this study, elective intubation of pediatric patients for the short-term protection of the airway during medical or surgical procedures does not qualify as assisted ventilation, provided that there is no parenchymal pulmonary lesion 24 hours after extubation.
Documented allergy to psoralens

Where it is running

UCLA Medical Center — Los Angeles, California, United States
Stanford University — Palo Alto, California, United States
Yale-New Haven Hospital — New Haven, Connecticut, United States
Emory University — Atlanta, Georgia, United States
University of Maryland — Baltimore, Maryland, United States
Beth Israel — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
St. Louis Children's Hospital — St Louis, Missouri, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Memorial Sloan Kettering — New York, New York, United States
Strong Memorial Hospital — Rochester, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
East Carolina University Hospital — Greenville, North Carolina, United States
TriHealth Cancer Institute — Cincinnati, Ohio, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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