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A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of ruxolitinib in combination with P-Gemox in adult patients with newly diagnosed aggressive NK cell leukemia

A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of ruxolitinib in combination with P-Gemox in adult patients with newly diagnosed aggressive NK cell leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086092
Enrollment
Unknown
Registered
2024-06-25
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

aggressive NK cell leukemia

Interventions

study group:ruxolitinib 10mg bid D1-21 pegaspargase 2500 IU/m2 D2 gemcitabine 1000mg/m2 D1,D8 oxaliplatin 130mg/m2 D1

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. According to the fifth edition of WHO Classification of lymphohematopoietic tumors, the patient was pathologically diagnosed as aggressive NK cell leukemia (ANKL). 2. 18-80 years old; 3. No systemic anti-lymphoma therapy; 4. Women of childbearing age must be confirmed not to be pregnant through pregnancy tests, and are willing to take effective contraceptive measures during the test period and =12 months after the last dose of medication; Pregnant and lactating women cannot participate; All male subjects used contraception during the study period and =3 months after the last dose; 5. Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Severe mental illness 2.HIV infection 3. Severe renal dysfunction (glomerular filtration rate 20) 5. Known history of other active neoplasm 6. Pregnant or nursing women 7. Inability to understand or follow the study protocol

Design outcomes

Primary

MeasureTime frame
Overall survival;Safety;

Secondary

MeasureTime frame
overall response rate;complete remission rate;Progression-free survival;

Countries

China

Contacts

Public ContactHongyan Tong

The First Affiliated Hospital, Zhejiang University School of Medicine

tonghongyan@zju.edu.cn+86 87235560

Outcome results

None listed

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