Clinical trial NCT06254742: A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies
Official title: Study on Preference and Safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study is being conducted to evaluate the preference, and safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of chemotherapy-related moderate to severe neutropenia of Patients with nonmyeloid malignancies.


Eligibility criteria: Inclusion Criteria:

1. The patient signs the informed consent form and voluntarily participate in this study;
2. Age ≥18 years;
3. Have the ability to read and understand Chinese;
4. Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumor diseases (including solid tumors and malignant hematologic tumors);
5. Patients who plan to receive at least two consecutive cycles of anti-tumor trerapy based on a moderate to high FN risk chemotherapy regimen (see Appendix 4 for details of the chemotherapy regimen);
6. The investigator determines that the patient are eligible to receive administration of HHPG-19K injection and Auto-HHPG-19K injection (delivered through an adhesive patch automatic drug delivery device);
7. ECOG (Eastern Cooperative Oncology Group score) score 0-1 points;
8. Expected survival ≥3 months;
9. Good function of major organs, meeting the following criteria:

   1. Neutrophil count ≥1.5 ×109/L;
   2. Platelet count≥75 ×109/L;
   3. Hemoglobin level≥80 g/L.
10. Women of childbearing age must take a blood pregnancy test within 3 days before randomization, and the result is negative, and they should not be lactating. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to approach highly effective contraceptive methods from the day of signing the informed consent form until at least 6 months after the last administration (for female subjects) or 3 months after the last administration (for male subjects).

Exclusion Criteria:

1. Women who are planning to become pregnant or breastfeeding;
2. Allergic to polyacrylate adhesives, HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor and other preparations expressed in Escherichia coli;
3. Having a history of bone marrow transplantation and/or stem cell transplantation;
4. Other situations deemed unsuitable for inclusion in the study as determined by the investigator

Primary outcomes:
measure: The preference ratio of patients for HHPG-19K and Auto-HHPG-19K , as assessed in the Patient Preference Questionnaire"Considering your overall experience in this study, which administration method do you prefer for drug injection?"
timeFrame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
Secondary outcomes:
measure: The preference ratio of physicians and nurses for HHPG-19K and Auto-HHPG-19K, according to the question in the "Preference Questionnaire of Physician and Nurse": "Which formulation would you recommend for patient use?"
timeFrame: approximately 2 months
measure: Factors influencing patients' preference for HHPG-19K and Auto-HHPG-19K.
timeFrame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days).
measure: Factors influencing the preference of physician and nurse for HHPG-19K and Auto-HHPG-19K
timeFrame: Evaluation after experiencing at least 3 cases of HHPG-19K injection and 3 cases of Auto-HHPG-19K injection therapy
measure: The injection experience of patients using HHPG-19K and Auto-HH PG-19K
timeFrame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
measure: The proportion of successful administration of HHPG-19K Injection within 24h-72h after the end of chemotherapy drugs.
timeFrame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
measure: Incidence of adverse events Auto-HHPG-19K Injection.
timeFrame: From screening period to the last follow-up visit(approximately up to 2 months )
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospita
state: Henan
Study officials:
References: