Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD

NCT05021276 | Unknown Phase 4

• 1 other identifier: GVHD-001
• Study Type: interventional
• Target: 50
• 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 recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.

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 (7)

• ORR at d14/d56

  day 14, day 56

• Time to response

  through study completion(median 12 days according to previous study)

• 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)

ruxolitinib+basiliximab

EXPERIMENTAL

Patients with grade 3-4 steroid-refractory aGVHD receive combined therapy of basiliximab and ruxolitinib.

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

Ruxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease.

Also known as: basiliximab

ruxolitinib+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 primary 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).
• 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.
• Ecg: QT interval \> 450 ms.
• Allergic to arsenic agent.
• Pregnant or lactating women.
• Expected survival \<60 days.
• Undergoing other drug clinical trials.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Soochow Hopes Hematonosis Hospital: collaborator
• The Second People's Hospital of Huai'an: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Publications (1)

• Zhou F, Pan T, Li X, Du F, Ma X, Zhang Y, Wu D, Han Y, Xue S, Miao M, Tao T, He X, Chen S. Exploration of efficacy and safety of combined therapy of basiliximab with ruxolitinib for grade 3-4 steroid-refractory acute graft-versus-host disease: a registered clinical trial (NCT05021276). Bone Marrow Transplant. 2023 Aug;58(8):959-961. doi: 10.1038/s41409-023-02005-4. Epub 2023 May 30. No abstract available.

  PMID: 37253803 DERIVED

MeSH Terms

Interventions

ruxolitinib; Basiliximab

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: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 25, 2021
• Study Start: December 15, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 15, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)