Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR

Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness

The purpose of this study is to improve the platelet level of PTR patients; Prevent and improve bleeding; Help patients to successfully through the bone marrow suppression period after chemotherapy; Reduce the overall rate of PTR and allo-immunity; Saving platelet resources and reducing blood burden.

Study Overview

• Status: Recruiting
• Conditions: Platelet Transfusion Refractoriness
• Intervention / Treatment: Other: Cryopreserved autologous platelet transfusion

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Han, PhD,MD; Phone Number: 13901551669; Email: hanyue@suda.edu.cn
• Study Contact Backup: Name: Depei Wu, PhD,MD; Phone Number: 13951102021; Email: wdepeisz@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • First Affiliated Hospital of Soochow University
      • Contact: Yue Han, PhD,MD; Phone Number: 13901551669; Email: hanyue@suda.edu.cn
      • Principal Investigator: Yue Han, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ALL，AML，MDS, CML,CLL that suffered from PTR before, with or without HLA antibodies
• The platelet level >150*10E9/L when considering autologous PLT collection
• Age less than 70 years
• The expected life more than 3 months
• Agree to receive autologous platelet cryopreservation and infusion treatment, and sign the informed consent form

Exclusion Criteria:

• Blast cells are found in peripheral blood or bone marrow
• Patients with bacteremia or sepsis
• Coagulation function abnormality
• Patients who have a history of thrombosis and are receiving anticoagulant treatment
• Severe bleeding within 2 weeks
• Participate in another clinical study within 1 month, and have treatment with potential impact on platelets
• Patients with mental disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Patients receive cryopreserved autologous platelet transfusion	Other: Cryopreserved autologous platelet transfusion; Autologous PLTs were collected and transfused as an individualized treatment approach, when the platelet is less than 20*10E9/L or severe bleeding occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	Platelet level detection	1 hour after transfusion
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion	Platelet level detection	24 hours after transfusion
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)	Corrected count increment，CCI	1 hour after transfusion
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)	Corrected count increment，CCI	24 hours after transfusion
The total platelet transfusion volume		1 month
Incidence of adverse events after blood transfusion		1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of platelet recovery after chemotherapy	1 month
The overall incidence of PTR	2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Yue Han, PhD,MD, First Affiliated Hospital of Soochow University

Publications and helpful links

General Publications

• Cid J. Autologous cryopreserved platelets to overcome immune platelet refractoriness. Transfusion. 2016 Oct;56(10):2403-2404. doi: 10.1111/trf.13758. No abstract available.
• Funke I, Wiesneth M, Koerner K, Cardoso M, Seifried E, Kubanek B, Heimpel H. Autologous platelet transfusion in alloimmunized patients with acute leukemia. Ann Hematol. 1995 Oct;71(4):169-73. doi: 10.1007/BF01910313.
• Schiffer CA, Aisner J, Wiernik PH. Frozen autologous platelet transfusion for patients with leukemia. N Engl J Med. 1978 Jul 6;299(1):7-12. doi: 10.1056/NEJM197807062990102.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): January 10, 2025
• Study Completion (Anticipated): January 10, 2025

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cryopreserved autologous platelet
• Other Study ID Numbers: 20221108091732885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No