A single-arm, open-label, phase 2 clinical trial of Tislelizumab combined with Lucitanib for secondary hemophagocytic lymphohistiocytosis.

A single-arm, open-label, phase 2 clinical trial of Tislelizumab combined with Lucitanib as first-line therapy for secondary hemophagocytic lymphohistiocytosis.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041490

Enrollment

Unknown

Registered

2020-12-27

Start date

2021-01-01

Completion date

Unknown

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemophagocytic lymphohistiocytosis

Interventions

Study group:Tislelizumab combined with Lucitanib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years; 2.The diagnosis secondary HLH can be established if at least 5 below is fulfilled. (1) Fever, body temperature >= 38.5 degrees C (2) Splenomegaly (3) Cytopenias (affecting 2 of 3 lineages in the peripheral blood): Hemoglobin = 3.0 mmol/L (i.e., >=265mg/dl), Fibrinogen = 500ug/L; (8) Soluble CD25 (i.e., soluble IL-2 receptor) >= 2,400U/ml. 3.ECOG <= 3; 4.Subject or subjects legal personal representative fully understand and voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1.HLH secondary to hematological malignancies such as lymphoma and leukemia. 2.HLH secondary to hematological diseases including hemophilia and congenital factor deficiencies?(CFDs). 3.Have any other malignancies. 4.Received allo-HSCT or solid organ transplantation before. 5.Experienced one or more following conditions of cardiovascular disease. (1) Have unstable or symptomatic angina. (2) Have myocardial infarction within 6 months before enrollment. (3) Have a history of serve arrhythmia. (4) Unstable or symptomatic congestive heart failure. (5) LVEF lower than the normal value. 6.Nursing women. 7.Inability to understand or to follow study procedures.

Design outcomes

Primary

Measure	Time frame
Overall response;Mortality;	—

Countries

China

Contacts

Public ContactShi Jun

Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College

shijun@ihcams.ac.cn+86 13752253515

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026