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Adverse Effects of ATG/ALG Therapy in Aplastic Anemia

ConditionAplastic Anaemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the diagnostic criteria for aplastic anemia (Camitta criteria);

Receiving ATG/ALG immunosuppressive therapy for the first time;

Disqualifiers

Previously received hematopoietic stem cell transplantation;

Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;

Trial population

Aplastic anemia patients treated with ATG/ALG

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ATG/ALG

    Drug

    Participants will receive ATG/ALG according to standard dosing protocols as per clinical guidelines. During treatment, we will monitor and document any adverse reactions, including their type, severity, duration, and any necessary interventions or changes in treatment plan.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with aplastic anemia undergoing ATG or ALG treatment1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with serum sickness and its severity

Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

Time frame
Within 4 weeks after ATG/ALG infusion

Secondary outcomes

1

Percentage of patients with liver and kidney function damage and its severity

Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

Time frame
During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion
2

Percentage of patients with infusion reaction and its severity

Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

Time frame
During ATG/ALG infusion(typically from d1 to d6)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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