Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02549222 |
| Other study ID # |
CLI 00112 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
May 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Cerus Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
The study will have a pilot run-in period and two sequential cohort groups for each center.
Pilot Run-in Period The pilot run-in period will be conducted in each center with a group of
at least 5 patients exposed only to conventional PCs, who provide informed consent for data
collection. The purpose of this pilot run-in is to evaluate study logistics and data
collection methods within each study center. Data collection will not differ from that
required in the two sequential patient cohorts. The data from the pilot phase will be
included in the data analysis for the treatment comparisons.
Control and INTERCEPT Cohorts Following the run-in period, the study will be conducted in two
sequential cohort periods. Informed consent for data collection without study specific
treatment intervention, and under patient confidentiality, will be required for both cohorts
prior to any study procedure.
During the Control cohort period, patients will have study data collected following
transfusion with only conventional PCs for up to 21 days of transfusion support, as
clinically indicated in a manner that is consistent with the local standard of care. During
the INTERCEPT phase, patients will receive only INTERCEPT PCs under the same clinical
treatment guideline. Patients will be transfused with only study PCs of the assigned
treatment type (Conventional or INTERCEPT) in each cohort. Patients enrolled in the
Conventional control cohort will be excluded from participating in the study in the INTERCEPT
cohort.
Enrollment will be stratified by study center and type of primary disease therapy
(chemotherapy only or HSCT with myeloablative, non-myeloablative, or reduced intensity
conditioning).
For both cohorts, patients will be supported with study PC transfusions for a maximum of 21
days or until platelet transfusion independence. Patients are considered to have achieved
platelet transfusion independence if more than 5 days elapse after exposure to a study PC
transfusion. When a patient achieves platelet independence, the patient will have completed
the study PC transfusion period (even if they subsequently resume another cycle of platelet
support).
For the pilot phase and both cohort periods, all baseline O2 saturation values if available
in the medical record should be recorded on eCRF. O2 measures associated with any form of
respiratory therapy (except for room air ventilation) should be recorded with the indicated
respiratory therapy for each day of therapy. If multiple measures are available in the
medical record on a single day, then the worst value will be recorded.
Data collection for all participants will comprise: patient baseline disease characteristics,
including primary disease, type of HSCT (auto, allo, cord blood, matched related or matched
unrelated) or type of chemotherapy, and medications at study entry and during the study
observation period. Patient clinical respiratory status, including, if available, a chest
imaging study at baseline and O2 saturation by non-invasive pulse oximetry if available in
the medical record prior to the first study transfusion in each cohort period, will also be
recorded.
Within each study cohort, patients will be assessed for the primary outcome measure of
assisted ventilation for a maximum of 28 days (7 days surveillance following up to of 21 days
of study PC transfusion support). Patients with assisted ventilation within the defined
timeframe will be further assessed for ARDS using the Berlin criteria by both the
Investigator (based on diagnoses documented in the medical record) and the Pulmonary
Adjudication Panel. Furthermore, AEs (including TR) will be collected from the primary
medical record for 24 hours following the initiation of each study PC transfusion.; SAEs
(including ARDS), CSPAEs (Grade 2 or higher AEs affecting the Respiratory System) and
mortality will be collected for 7 days post each study transfusion (or until hospital
discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner).
Investigators will assess the intensity of each AE and SAE and provide their assessment of
the relationship of each AE and SAE to the study transfusion. Patients who experience the
outcome of assisted ventilation, ARDS, or CSPAEs will be assessed as detailed in Assessment
of Pulmonary Adverse Events in the synopsis and in Protocol Section 8.1.
For patients who achieve platelet independence before Study Day 21, AEs will be collected for
24 hours after initiating the last study platelet transfusion prior to platelet independence;
the outcome of assisted ventilation, SAEs, ARDS, CSPAEs, and mortality will be collected for
7 days after the last study PC transfusion prior to platelet independence (or until hospital
discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner).
For patients who require more than 21 days of PC transfusion support, AEs will be recorded
for up to 24 hours after the initiation of the last platelet transfusion up to and including
Day 21; the outcome of assisted ventilation, SAEs, ARDS, CSPAEs, and mortality will be
collected for up to a maximum of 28 days (7 days after up to 21 days of platelet transfusion
support),7 days after initiating the last study transfusion within the 21-day study
transfusion period (or until hospital discharge/discontinuation of outpatient platelet
transfusion support, whichever is sooner). The lowest daily O2 saturation values in the
medical record will be recorded on the eCRF as well.
Study-specific research personnel will review the patient medical record and record study
outcomes on electronic Case Report Forms (eCRF). The intensity of AEs and SAEs will be graded
according to the most recent version of the Common Terminology Criteria for Adverse Events
(CTCAE) classification system. TR will also be assessed following the CDC National Healthcare
Safety Network (NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol (NHSN
Protocol).
