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Safety of a New Technology for the Treatment of Whole Blood (POINT1africa)

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ClinicalTrials.gov Identifier: NCT03486054
Recruitment Status : Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Cerus Corporation
Information provided by (Responsible Party):
Swiss Transfusion SRC

Brief Summary:

The pathogen inactivation (PI) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult cancer patients with anemia.

This study has a two-stage design. Stage 1 is designed as a randomized, double-blind stage, followed by Stage 2, an open-label, single arm treatment escalation stage. The aim is to explore the safety of the whole blood product treated with a PI system using amustaline and glutathione.

The study will enroll 30 patients with anemia due to underlying cancer. In stage1, 20 patients will be randomized either to treated WB (Test) or conventional WB (Control).

After safety assessment in Stage 1, Stage 2, a dose escalation stage will follow and enroll additional 10 patients in need of 2 WB products administered successively to correct anemia.


Condition or disease Intervention/treatment Phase
Safety Issues Device: INTERCEPT Device: Conventional whole blood Device: INTERCEPT (dose escalation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stage 1: parallel assignement to experimental or control group Stage 2: Dose escalation group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized, double-blind Stage 1; single arm open label in Stage 2
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase I, Dose-Escalation Study for the Safety of Whole Blood Treated With Amustaline (S-303) and Glutathione (GSH), a Pathogen Inactivation System, and Transfused to Anemic Adult Cancer Patients.
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INTERCEPT
Transfusion with one bag of Whole blood treated with amustaline and glutathione, a pathogen inactivation (PI) system, ordered and administered to study patients by their treating physicians
Device: INTERCEPT
The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on a single unit of not leuco-reduced whole blood treated with amustaline and glutathione in CPD
Other Name: Experimental

Active Comparator: Conventional Whole Blood
Transfusion intervention with one conventional whole blood ordered and administered to study patients by their treating physicians.
Device: Conventional whole blood
The conventional whole blood unit is collected according to local standards and procedures at the blood center and stored in Citrate Phosphate Dextrose (CPD), an anticoagulant solution.
Other Name: Control

Experimental: INTERCEPT (dose escalation)
Transfusion intervention with two Whole blood treated with amustaline and glutathione, a pathogen inactivation system, ordered and administered to study patients by their treating physicians.
Device: INTERCEPT (dose escalation)
The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on two units of not leuco-reduced whole blood treated with amustaline and glutathione in CPD.
Other Name: Escalation




Primary Outcome Measures :
  1. Severe Transfusion Reactions [ Time Frame: 24 hours ]
    The primary safety outcome will be assessed by the occurrence of transfusion reactions >= grade 2 according to the Swissmedic transfusion reaction grading and causality criteria (Appendix 1), during the first 24 hours following administration of each study transfusion, with probable, possible or certain causality to the transfused product.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 75 (+/-15) ]
    All adverse events including transfusion reactions from start of the first transfusion to day 28 (+/-3) and all SAEs within 75 (+/-15) after study transfusion.

  2. Treatment-emergent antibodies [ Time Frame: 75 (+/-15) ]
    Treatment-emergent antibodies to INTERCEPT Red Blood Cells (RBC)s within 75 (+/-15) days after study transfusion

  3. Treatment-emergent auto-antibodies [ Time Frame: 75 (+/-15) ]
    Treatment emergent auto-antibody within 75 (+/-15) days after study transfusion

  4. Hemoglobin increment [ Time Frame: 24 hours ]
    The hemoglobin increment post transfusion will be calculated as the difference between the hemoglobin value most proximate before the transfusion and approximately 24h post transfusion, adjusted by hemoglobin content transfused.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Stable anemic cancer patients treated in an ambulatory care setting (defined as patients that do not need to be hospitalized due to underlying cancer disease).

Inclusion criteria:

Patients fulfilling all of the following inclusion criteria are eligible for the study:

  1. Patient must be 18 years of age or older;
  2. Patient in Stage 1 must have a hemoglobin level of 6.0 - 7.9 g/dl or <10 g/dL with additional symptoms judged by the physician to be caused by anemia, and in both cases transfusion treatment with one whole blood product during the first 24 hours after transfusion is considered adequate or Patients in Stage 2 must have a hemoglobin level of <6.0 g/dl or <10 g/dL with additional symptoms judged by the physician to be caused by anemia, and in both cases transfusion treatment with two whole blood products during the first 24 hours after transfusion is considered adequate.
  3. Patient must be diagnosed with cancer.
  4. Patient must understand either English or Luganda. Illiterate patients can be consented by an impartial witness (see section 2.7), patients that are not familiar with one of these two languages cannot be included in the trial.
  5. Patient must have signed an informed consent, prior to initiation of any study-specific procedure / treatment.
  6. Patient must provide written informed consent for the trial. These patients may give consent for specimens collected during this study to be used in future research. Patients may participate in this trial and decline collection of specimens for future research.
  7. Patient must agree to be hospitalized for 24 hours after initiation of study transfusion;
  8. Female patients of childbearing potential must:

    1. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and
    2. use at least one method of birth control that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. These include combined oral contraceptives, implants, injectable, some intrauterine devices, sexual abstinence or vasectomized partner. The selected method must be used for the duration of study participation that means from day 1 (day of initiation of study transfusion) until day 75 (end of study).

Exclusion criteria:

The presence of any one of the following exclusion criteria will lead to exclusion:

  1. Patient has blood group AB.
  2. Patient has a positive antibody screening test reaction specific to red blood cells treated by amustaline and glutathione (GSH).
  3. Patient has a positive red cell alloantibody screening (IAT).
  4. Patient has clinical-significant bleeding described as grade 2 or more according to CTCAE v4.03.
  5. Patient has a lifelong history of major bleeding due to congenital or acquired coagulopathy.
  6. Patient has a history of thrombosis or thromboembolic events.
  7. Patient has blood in urine or feces in the last 30 days.
  8. Patient has a pre-transfusion thrombocyte count of < than 50 Giga/l (x109).
  9. Patient takes oral, intravenous or sub-cutaneous prophylactic or therapeutic anticoagulants.
  10. Patient has a temperature increase of ≥ 2 °C within 24 hours before transfusion.
  11. Patient has clinical signs of ongoing sepsis, including fever > 39°C with signs of a systemic, inflammatory response.
  12. Patient has abnormal activated partial thromboplastin time (aPTT) and/or abnormal prothrombin time (PT) laboratory results.
  13. Patient had a whole blood transfusion or red blood cell concentrates transfusion within 2 weeks prior to enrollment.
  14. Patient participates (or is participating) in any other type of clinical study either concurrently or within the previous 30 days: investigational blood products, nutrition, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Studies of psychology or socioeconomic issues are not grounds for exclusion.
  15. Patient has abnormal bilirubin levels and /or clinical signs of jaundice.
  16. Patient is pregnant or breast feeding.
  17. Patient shows an inability to comply with the protocol in the opinion of the investigator.
  18. Patient has been previously treated with other pathogen-reduced blood products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486054


Contacts
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Contact: Soraya Amar, MD +41 31 380 8181 bsd@blutspende.ch
Contact: Anja Grzesiczek +41 31 380 8181 bsd@blutspende.ch

Sponsors and Collaborators
Swiss Transfusion SRC
Cerus Corporation
Investigators
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Study Director: Soraya Amar, MD Transfusion SRC

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Responsible Party: Swiss Transfusion SRC
ClinicalTrials.gov Identifier: NCT03486054     History of Changes
Other Study ID Numbers: 702004 - 2138
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Transfusion SRC:
Anemia
Transfusion
Pathogen inactivation
low-resource
Sub-saharan Africa
Uganda
Transfusion-transmitted infection
dose escalation
Whole blood