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MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

ConditionsGVHDAcute Stem Cell Transplant Complications
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-60
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ruxolitinib

    Drug

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: RuxolitinibExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 100 post HCT

Secondary outcomes

1

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

Time frame
6 months
2

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

Time frame
1 year and 2 years
3

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

Time frame
1 year and 2 years
4

Progression-free survival

Progression-free survival of this group of patients at the end of 1 year and 2 years

Time frame
1 year and 2 years

Other outcomes

Sponsors and contacts

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

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: