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A single-arm open and multi-center clinical study on the efficacy and safety of bortezomib combined with arsenic trioxide in the treatment of T-cell large granular lymphoblastic leukemia

A single-arm open and multi-center clinical study on the efficacy and safety of bortezomib combined with arsenic trioxide in the treatment of T-cell large granular lymphoblastic leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083630
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-30
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

T-LGLL

Interventions

test group:Bortezomib combined with arsenic trioxide chemotherapy

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: T-LGLL was clearly diagnosed according to WHO criteria 2: The disease state is primary or the treatment of immunosuppression is ineffective 3: There is at least one-line cytopenia: the absolute value of neutrophils is less than 0.5× 10 9/L, there are anemia symptoms, hemoglobin is less than 90g/L, and platelet count is less than 50× 10 9/L. 4: Aged 18 to 80 years 5: ECOG physical condition score was <= 2 6: No serious complications, such as liver failure, renal failure, heart failure 7: Must be able to understand the protocol, follow medical instructions and sign informed consent.

Exclusion criteria

Exclusion criteria: 1: Who is receiving either a chemotherapy regimen or a targeted drug 2: Major surgery (excluding diagnostic surgery) performed within the past 4 weeks 3: Evidence of central nervous system disease 4: Active infectious diseases, such as HBV, HCV, tuberculosis 5: Serious diseases that may limit patients' participation in the trial (such as progressive infection, uncontrolled diabetes, severe cardiac insufficiency or myocardial infarction, liver and kidney dysfunction, etc) 6: Participating in other clinical trials or participating in clinical trials of other drugs within 3 months 7: Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during treatment and within a year thereafter 8: There are allergies or contraindications to any of the drugs involved in the protocol 9: Unable to understand the experimental protocol, follow the doctor's advice, or refuse to sign the informed consent 10: The researchers say it is not appropriate for patients who are treated with this regimen.

Design outcomes

Primary

MeasureTime frame
Complete remission rate after 2 times of chemotherapy;

Secondary

MeasureTime frame
adverse event incidence rate;

Countries

China

Contacts

Public ContactJinsong Yan

Second Hospital of Dalian Medical University

yanjsdmu@126.com+86 177 0987 1028

Outcome results

None listed

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