Last updated: August 3, 2021
Sponsor: Zhengzhou University
Overall Status: Active - Recruiting
Phase
4
Condition
Lymphoma
Histiocytoma
Treatment
N/AClinical Study ID
NCT04999878
hnslblzlzx20210601
Ages 14-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histopathologically proven T-cell lymphoma or NK/ T-cell lymphoma;
- Comply with HLH-2004 diagnostic criteria;Hemophagocytic syndrome can be diagnosed wheneither of the following two criteria is met: A. Molecular diagnosis is consistent with hemophagocytic syndrome. Pathologicalmutations were found in known pathogenic genes related to hemophagocytic syndrome,such as PRF1, UNC13D, STX11, STXBP2, RAB27A, LYST, SH2D1A, BIRC4, ITK, AP3B1, MAGT1,CD27, etc. B. Meet 5 of the following 8 indicators I. Fever: The body temperature was > 38.5℃,lasting > for 7 days. II. Splenomegaly . III. Hemocytopenia (involving two or threelines of peripheral blood) : hemoglobin < 90g/L, platelet < 100×10^9/L, neutrophils < 1.0×10^9/L and not caused by reduced hematopoietic function of bone marrow. IV. Hypertriglyceridemia and/or hypofibrinogenemia: triglyceride > 3mmol/L or 3standard deviations higher than the same age, fibrinogen < 1.5g/L or 3 standarddeviations lower than the same age. V. Hemophagocytes are found in bone marrow, spleen, liver, or lymph nodes. VI.NK cellactivity decreased or absent. VII. Elevated serum ferritin: ferritin ≥500μg/L. VIII.Elevated sCD25 (soluble interleukin-2 receptor).
- Ages 14-75 years.
- Expected survival of more than 1 week.
- Patients with left ventricular ejection fraction > 50%, no major bleeding of activeinternal organs (digestive tract, lung, brain, etc.), and oxygenation index > 250.
- Patients have good compliance with the planned treatment and follow-up, can understandthe research process of this study and sign the written informed consent.
Exclusion
Exclusion Criteria:
- Three or more drugs including ruxolitinb, etoposide, pemasparase, gemcitabine orcisplatin were used simultaneously in the previous 28 days.
- Pregnant or lactating women and patients of reproductive age who refuse to takeappropriate contraceptive measures during the course of this study. If the patient wasmale, they refused to use adequate contraception or sperm donation during the studyperiod and for 3 months after the last study of lymphoma-related chemotherapy drugs.
- Allergic to any medication in the program.
- Grade III or IV heart disease based on the New York Heart Association (NYHA) score.
- Major active bleeding of internal organs (including gastrointestinal bleeding,alveolar bleeding, intracranial bleeding, etc.).
- Acute pancreatitis.
- People infected with HIV (HIV antibody positive).
- HBV DNA copy number is >10^4/ml in patients with acute or chronic active hepatitis B,and HBV DNA copy number is >10^4/ml in patients with acute or chronic active hepatitisC (HCV antibody positive, HCV RNA negative acceptable).
- Participate in other clinical investigators.
- The investigators identified patients who were not eligible for the study.
Study Design
Total Participants: 30
Study Start date:
May 30, 2021
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaActive - Recruiting
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