Clinical Study on Preventing CIN for Non-Hodgkin's Lymphoma with Icaritin Soft Capsules

Phase 1

• Conditions: CI

• Registration Number: ITMCTR2200005910
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must meet all of the following criteria to be enrolled in the study:
1)Male or female patients aged over 18 years;
2)The newly diagnosed patients with non-Hodgkin's lymphoma, and the lymphoid tissue tumor type is B-cell lymphoma patients, CD20 antigen positive;
3)Patients who previously received R CHOP in Cycle 1-2 of chemotherapy and only experienced grade I/II neutropenia, and are goning to receive R CHOP therapy in subsequent cycles;
4)Bone marrow, liver and kidney function meet the following requirements (white blood cells = 3.5 × 10*9/Lneutrophils = 1.5 × 10*9/L Platelets = 80 × 10*9/L, hemoglobin = 75 g/L; serum bilirubin = 1.5 × ULN; alanine aminotransferase and aspartate aminotransferase = 2.5 × ULN or = 5 × ULN with liver metastasis; alkaline phosphatase = 2.5 × ULN or = 5 × ULN with liver metastasis; serum creatinine = 1.5 × ULN or creatinine clearance > 50 mL/min), no contraindications to chemotherapy;
5)Prothrombin time (PT) and international normalized ratio (INR) = 1.5 × ULN, activated partial thromboplastin time (APTT) = 1.5 × ULN;
6)Expected survival = 6 months;
7)ECOG score = 2;
8)No psychiatric history, no severe psychological disorders and cognitive dysfunction;
9)Women of childbearing potential must have a negative pregnancy test within 7 days before the start of treatment; men of childbearing potential: take effective contraceptive measures during treatment and within 3 months after the end of treatment;
10)Patients who did not participate in other clinical trials before screening; patients who failed in screening in other trials but met the requirements of this trial can be excluded;
11)Voluntary participation in this study, signed informed consent, and good compliance.

Exclusion Criteria

Patients meeting any of the following criteria were not to be enrolled in the study
1)Use of drugs that have an effect on white blood cells (such as immunosuppressive agents, non-steroidal anti-inflammatory drugs, granulocyte colony-stimulating factor and other western medicine or traditional Chinese medicine with a clear increase or decrease in white blood cells), tonic drugs (such as ginseng, Cordyceps, etc.);
2)The adverse reactions caused by previous anti-tumor treatment have not recovered to CTCAE 5.0 grade = 1 (except for toxicities without safety risk as judged by investigators, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);
3)History of severe heart, liver, lung, brain, kidney and other vital organ system diseases, autoimmune diseases, myelodysplastic syndrome or severe blood system diseases accompanied by sickle cell disease;
4)Patients with relapsed or refractory non-Hodgkin's lymphoma;
5)Patients with lymphoma bone marrow infiltration confirmed by bone marrow cytology and flow cytometry;
6)Patients with hypersplenism;
7)Patients who have received hematopoietic stem cell transplantation or organ transplantation;
8)Human immunodeficiency virus (HIV) seropositive;
9)Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml), HCV-Ab positive and HCV-RNA > lower limit of detection in the study site;
10)Patients planned to receive radiotherapy at the same time;
11)Patients who intend to use other anti-tumor therapy during the study, or have excessive surgery or major trauma within 28 days before enrollment, or are expected to require major surgery during the study;
12)Patients with other malignant tumors within 5 years before enrollment, except for cured cervical carcinoma in situ and cured cutaneous basal cell carcinoma;
13)Active infection before enrollment or systemic anti-infective treatment within 72 hours before chemotherapy;
14)Patients with mechanical eating disorders such as gastrointestinal obstruction and masticatory dysphagia; patients with frequent vomiting, or patients with hematemesis and hematochezia requiring fasting;
15)Pregnant and lactating women;
16)Potential or known hypersensitivity to any component of the study medication;
17)Patients with poor compliance or mental disorders who cannot take medicine regularly, which affects the efficacy evaluation or safety evaluation;
18)Other conditions that, in the opinion of the investigator, make participation in the study unsuitable.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of neutropenia (ANC < 1.5 × 10*9/L) within the first study cycle.;

Secondary Outcome Measures

Name	Time	Method
6)Time from neutrophil minimum value to recovery above 1.5 × 10*9/L in the first treatment cycle; ;8)Incidence of infection within each cycle of chemotherapy; ;2)Incidence and duration of Grade 3-4 neutropenia (ANC < 1.0 × 10*9/L) within each cycle of chemotherapy; ;3)Neutrophil minimum value within each chemotherapy cycle; ;5)Incidence of Neutropenic Fever (FN) by Chemotherapy Cycle ;7)The proportion of subjects who experience Grade 3 (ANC < 1.0 × 10*9/L) or Grade 4 neutropenia (ANC < 0.5 × 10*9/L) for at least 1 day in each chemotherapy cycle; ;1)Incidence and duration of leukopenia (WBC < 3.5 × 10*9/L) and neutropenia (ANC < 1.5 × 10*9/L) within each chemotherapy cycle; ;4)Dynamic changes of neutrophils from baseline in each cycle of chemotherapy; ;10)Incidence of chemotherapy agent dose modifications, dose delays and treatment discontinuations within each chemotherapy cycle. ;9)Proportion of antibiotic, G-CSF and other treatments and drugs used in each chemotherapy cycle; ;