MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

GVHD Clinical Trial

Official title:

The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Ruxolitinib

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075225
• Other study ID #: HXMAP 2.0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: October 2023
• Source: Sichuan University
• Contact: Jie Ji, MD
• Phone: 86-28-85422373
• Email: jieji[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• Effect of MAGIC algorithm probability guided preemption of aGVHD with ruxolitinib on prevention of severe aGVHD.

Participants will take ruxolitinib with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.

Researchers will compare patients who don't receive preemption of aGVHD with ruxolitinib to see if there is an improvement in severe aGVHD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).

• Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.

• GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.

• The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted

• Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.

• ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days prior to enrollment.

• Signed and dated written informed consent obtained from patient or legal representative.

Exclusion Criteria:

• Patients who develop acute GVHD prior to start of study drug

• Patients at very high risk for relapse post HCT as defined by very high disease risk index

• Patients participating in a clinical trial where prevention of GVHD is the primary endpoint

• Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)

• Patients who are pregnant

• Patients on dialysis within 7 days of enrollment

• Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.

• Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of ruxolitinib

Related Conditions & MeSH terms

• GVHD

Intervention

Drug:
• Ruxolitinib
Ruxolitinib is asministrated with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chendu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of High Risk Patients Who Develop Grade III or IV aGvHD	Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT	Day 100 post HCT
Secondary	Number of Participants With Non-relapse Mortality (NRM)	Number of participants with NRM - deaths which could not be attributed to disease relapse or progression. Nonrelapse mortality defined as death without prior relapse at 6 months	6 months
Secondary	Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment	Number of participants with chronic GVHD requiring systemic steroid treatment. Chronic GVHD Requiring Systemic Steroid Treatment: defined as the development of symptoms of chronic GVHD according to NIH Consensus Criteria that require treatment with oral or intravenous corticosteroids at the end of 1 year and 2 years	1 year and 2 years
Secondary	GvHD free and relapse free survival	Survival of patients without grade 3 or 4 aGvHD or disseminated cGvHD or relapse of disease at end of 1 year post HCT at the end of 1 year and 2 years	1 year and 2 years
Secondary	Progression-free survival	Progression-free survival of this group of patients at the end of 1 year and 2 years	1 year and 2 years
Secondary	Overall survival	Overall survival of this group of patients at the end of 1 year and 2 years	1 year and 2 years
Secondary	Number of Participants With Relapse	Number of participants with relapse at one year and 2 years. Relapse defined as recurrence of disease that required transplant.	1 year and 2 years
Secondary	Number of Participants With Serious Infections	Number of participants with serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network). Serious Infection: Defined as bacterial, fungal, viral or parasitic infections that required oral or intravenous treatments such as antibiotics	1 year and 2 years
Secondary	cytomegalovirus (CMV) reactivation	Number of participants with cytomegalovirus (CMV) reactivation at the end of 1 year and 2 years. CMV reactivation was defined as the presence of DNA copies exceeding 10^3/ml in plasma.	1 year and 2 years
Secondary	grade 2 or higher hemorrhagic cystitis	Number of participants with grade 2 or higher hemorrhagic cystitis at the end of 1 year and 2 years, which was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).	1 year and 2 years
Secondary	MAGIC algorithm probability (MAP) change	The change in the patient's MAGIC algorithm probability (MAP) at each time	Day 28 post HCT