Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

NCT06066840 | Unknown Phase 4

• 1 other identifier: GVHD002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The investigators try to observe the efficacy and safety of application of vedolizumab, anti-CD25 monoclonal antibody and rapid reduction of glucocorticoids in the treatment of grade 3-4 steroid-refractory aGVHD(SR-aGVHD) with lower gastrointestinal involvement.

Conditions

Safety and Efficacy

Outcome Measures

Primary Outcomes (1)

• overall response rate at day 28

  The primary endpoint is the overall response rate (ORR) at day 28 defined as proportion of patients demonstrating partial (PR) or complete response (CR) without requirement for additional systemic immunosuppressive therapy (IST) at day 28 after second-line treatment initiates.

  day 28

Secondary Outcomes (4)

• ORR at d14/d56

  day 14, day 56

• Duration of response

  through study completion, an average of 1year

• OS

  through study completion, an average of 1year

• EFS

  through study completion, an average of 1year

Study Arms (1)

vedolizumab+basiliximab

EXPERIMENTAL

Patients with steroid-refractory aGVHD with gastrointestinal involvement receive combined therapy of vedolizumab and basiliximab.

Drug: Basiliximab; Drug: Vedolizumab

Interventions

Basiliximab DRUG

Basiliximab is a second-line treatment for steroid-resistant acute graft-versus-host disease.

Also known as: anti-CD25 monoclonal antibody

vedolizumab+basiliximab

Vedolizumab DRUG

Vedolizumab is a second-line treatment for steroid-resistant acute graft-versus-host disease.

Also known as: anti-α4β7 monoclonal antibody

vedolizumab+basiliximab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids) with gastrointestinal involvement.
• Age 18-65.
• ECOG score≤3.
• Must be able to understand and willing to participate in the study and sign the informed consent.

You may not qualify if:

• Refractory/secondary graft-versus-host disease.
• Severe complications such as myocardial infarction, chronic cardiac insufficiency,
• hepatic failure, renal insufficiency, etc.
• Clinically uncontrolled active infections.
• Other Malignant tumors with progression.
• Heart failure: EF\<30%, NYHA≥grade III.
• Pregnant or lactating women.
• Expected survival \<60 days.
• Undergoing other drug clinical trials.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Affiliated Hospital of Nantong University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

Basiliximab; PC61 monoclonal antibody; vedolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xuefeng He, doctor

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng He, doctor

CONTACT

86-18914031640; hexuefeng@suda.edu.cn

Fei Zhou, doctor

CONTACT

86-15051425673; zhoufei@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: October 4, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)