Clinical trial NCT04811443: DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
Official title: DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Solid Tumours Who Receive Myelosupressive Therapy
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solid tumors who are prescribed myelosuppressive therapy with empegfilgrastim supportive therapy to reduce the frequency, duration of neutropenia, the incidence of febrile neutropenia (FN) and infections manifested by FN, as part of routine clinical practice according to the approved indications of the appropriate drugs.

Brief summary: This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form;
2. Histologically verified diagnosis;
3. Age between 18 and 80 years;
4. If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug;
5. ECOG performance 0-2;
6. Haematology:

   * ANC ≥ 1,5 х 10(9) /L;
   * Platelets ≥ 100 х 10(9) /L;
   * Hemoglobin ≥ 90 g/L;
7. Biochemistry:

   * Creatinine ≤ 1,5 ULN;
   * Total bilirubin ≤ 1,5 ULN;
   * AST/ALT ≤ 2,5 ULN;
   * Alkaline phosphatase ≤ 5 ULN;
8. Life expectancy of at least 6 months from the date of the first drug administration in the study;
9. Ability of the patient to comply with the Protocol requirements.

Exclusion Criteria:

1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;
2. Systemic use of antibiotics less than 72 hours before the first drug administration in the study;
3. Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study;
4. Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;
5. Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study;
6. History of bone marrow or hematopoietic stem cell transplantation;
7. Presence of acute or active chronic infections;
8. Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods;
9. Inability to administer the drug by intravenous infusion or subcutaneous injection.

Primary outcomes:
measure: Relative dose-intensity (RDI) of the myelosupressive therapy course
timeFrame: 12 months
Secondary outcomes:
measure: The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control
timeFrame: 18 months
measure: The incidence of neutropenia leading to a dose reduction of cytostatic drugs and / or an increase of the interval between cycles when using empegfilgrastim supportive therapy compared with historical controls
timeFrame: 18 months
measure: RDI of chemotherapy courses performed in relation to nosology
timeFrame: 18 months
measure: RDI of chemotherapy courses performed in relation to treatment regimen
timeFrame: 18 months
measure: Any grade adverse events frequency
timeFrame: 18 months
measure: Grade 3-4 adverse events frequency
timeFrame: 18 months
measure: Serious adverse events frequency
timeFrame: 18 months
measure: Frequency of study withdrawal due to adverse events
timeFrame: 18 months
measure: The incidence of severe infections (grade 3-4)
timeFrame: 18 months
measure: Frequency of antibiotic prescription
timeFrame: 18 months
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
state: Yaroslavskaya Oblast
city: Belgorod
country: Russian Federation
facility: St. Josaphat Belgorod Regional Clinical Hospital
city: Voronezh
country: Russian Federation
facility: State Health Institution "Voronezh Region Clinical Oncology Dispansary"
Study officials:
References: