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

  • days left to enroll
  • participants needed
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 2 September 2021


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.


Adults ages 18-65 with grade 3-4 SR-aGVHD


Participants with grade 3-4 steroid-refractory acute GVHD (progression after 3 days or lack of improvement after 5 days of 1.5-2 mg/kg/d systemic steroids) receive combined therapy of basiliximab and ruxolitinib.

Basiliximab is given 20mg twice a week for week 1, and then once a week until GVHD of the participants reaches grade 1(3 episodes for minimum).

Ruxolitinib is given 5mg twice a day for one day and then escalates to 10mg twice a day if the participant is not administered with triazole antifungal agent.

The drug dose will be adjusted according to participants' clinical manifestations, blood cell count, infection status and so on.

For participants with lower gastrointestinal GVHD, intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range.

Best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion.

The investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. Then the investigators access the hematological disease status, aGVHD, cGVHD, infection state once a month.

Condition Safety and Efficacy
Treatment Ruxolitinib
Clinical Study IdentifierNCT05021276
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on2 September 2021


Yes No Not Sure

Inclusion Criteria

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 score3
Must be able to understand and willing to participate in the study and sign the informed consent

Exclusion Criteria

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
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