Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.

Disqualifiers

• (1) diagnosed as VOD/SOS.

(2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;

(3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.

(4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD25 antibody combined glucocorticoid as first-line treatment

    Drug

    CD25 antibody combined glucocorticoid as first-line treatment

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The remission rate of aGVHD

Time frame
28 days

Secondary outcomes

1

Incidence rate of severe aGVHD

Time frame
24 weeks
2

overall survival

Time frame
24 weeks
3

infection rate

Time frame
24 weeks
4

relapse rate

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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