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The efficacy and safety of perimentase in the treatment of adult malignant lymphoma

Prospective, non-controlled, post-marketing clinical study on the efficacy and safety of peimentonidase in the treatment of adult malignant lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016940
Enrollment
Unknown
Registered
2018-07-04
Start date
2011-12-01
Completion date
Unknown
Last updated
2018-07-09

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

Conditions

lymphoma

Interventions

one:CHOP-L
two:BFM-90

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with T cell NHL confirmed by histological morphology and immunohistochemistry included only 2 types: NK/T cell lymphoma and T lymphocytoma; 2. Circulating has at least one objectively measurable lesion; 3. Press aged 18 to 70 years male and female; 4. Superior primary care for patients; 5. ECOG 0 ~ ?, is expected to survive more than 3 month; 6. Pregnancy tests for women of child-bearing age must be negative; Men and women should agree to use effective contraceptives during treatment and within the following year; 7. Sign written informed consent form before screening test.

Exclusion criteria

Exclusion criteria: 1. Have central nervous system disease; 2. psychopath; 3. Other clinical studies are under way; 4. Severe infection; 5. Hepatic insufficiency, serum direct bilirubin, indirect bilirubin, transaminase were more than 2 times higher than normal.Serum total protein or albumin is lower than normal; 6. Renal insufficiency, creatinine clearance rate more than 2 times higher than normal, especially creatinine clearance rate less than 30ml/min. 7. Blood routine tests before admission: WBC < 3*10^9/L;Absolute number of neutrophils < 1.5*10^9/L; Platelet < 100*10^9/L (if bone marrow is not invaded); Absolute platelet count < 75*10^9/L (when bone marrow is invaded);Hb < 100 g/L; 8. Within 6 months prior to admission, the patient suffered from uncontrolled or severe cardiovascular diseases, including myocardial infarction, grade iii-iv heart failure, uncontrolled angina, etc.; 9. HIV antibody positive, HBsAg+ patients can be included in the group with hepatitis b DNA titer below 104 copies/ml after antiviral treatment; 10. Abnormal coagulation; 11. Women of childbearing age who were pregnant or lactating and were unwilling to use contraception during the study period.

Design outcomes

Primary

MeasureTime frame
ORR;CR;PR;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactJun Zhu

Beijing Cancer Hospital

zhujun@csco.org.cn+86 13910333346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026