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- Conditions
- eutropeniaMedDRA version: 20.0 Level: PT Classification code 10029354 Term: Neutropenia System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-002693-20-BG
- Lead Sponsor
- Ilkogen Ilac San. ve Tic. A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
[1] Male or female patients =18 years of age (Republic of Korea: =19 years of age)
[2] Patients with Non-Hodgkin’s Lymphoma confirmed by immunohistochemistry or flow cytometry:
- stage III-IV follicular lymphoma (Ann Arbor staging1) OR
- CD20 positive diffuse large B cell non-Hodgkin lymphoma*
[3] Patients who fulfil the criteria for receiving R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone) therapy for at least 2 cycles of 21 days each
[4] Patients who are about to receive the first two cycles of R-CHOP therapy within a series of several cycles (previous exposure to R-CHOP is allowed but in another series of cycles more than 3 months before randomization in the present trial)
[5] ECOG performance status 0, 1, or 2
[6] Life expectancy with treatment of at least 6 months
[7] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, attending scheduled visits, and compliance with protocol requirements as evidenced by providing signed written informed consent
*Stage III-IV
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
[1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study medication (e.g. sorbitol, fructose, or to latex) or to any of the components of R-CHOP therapy
[2] Known hypersensitivity to E coli-derived products (e.g., Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
[3] Burkitt's or B-lymphoblastic lymphoma
[4] Non-Hodgkin’s Lymphoma with CNS involvement
[5] Active infection requiring treatment with systemic (intravenous or oral) antiinfectives (antibiotic, antifungal, antiviral) at baseline
[6] Exposure to R-CHOP therapy or pegfilgrastim within the last 3 months before randomization
[7] Known lack of neutropenia in patients previously exposed to R-CHOP therapy
[8] Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
[9] Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia)
[10] Prior malignancy within the last 5 years, with the exception of surgically cured basal cell carcinoma, squamous skin cell carcinoma, or in situ carcinoma of the cervix
[11] Prior bone marrow or stem cell transplantation
[12] Severe hepatic impairment: serum bilirubin above 51.3 µmol/l (3 mg/dl) or serum albumin below 28 g/l (2.8 g/dl)
[13] Baseline neutrophil count <1.5 x 109/l or platelet count <100 x 109/l
[14] Demyelinating form of Charcot-Marie-Tooth syndrome
[15] Any of the following during the last month before randomization: pneumonia, pulmonary oedema, interstitial lung disease, lung infiltrations
[16] Sickle cell trait or sickle cell disease
[17] Major surgery within 2 weeks prior to randomization
[18] Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug
[19] Previous enrolment in this study
[20] Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice adequate contraceptive measures*. Reliable methods for women are hormonal contraceptives**, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence
[21] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[22] Alcohol/drug dependence or abuse (excluding tobacco abuse)
[23] Unreliability or lack of cooperation.
[24] Urinary outflow obstruction
[25] Impaired cardiac function: myocardial insufficiency, recent (last 6 months) myocardial infarction, severe arrhythmias
[26] Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis, severe and long-lasting febrile neutropenia) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
[27] Pregnant or bre
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the present trial is to assess the efficacy, safety, and tolerability of three doses of GX-G3 with the aim of selecting the optimal dose by comparing each of the doses with the reference product (Neulasta®). The major aim for including one group with delayed administration (250 µg/kg of GX-G3 on day 3 after R-CHOP dosing) is to evaluate the optimal point in time for dosing of the test product.;Secondary Objective: The secondary objectives of the present trial are to investigate the pharmacokinetics of GX-G3 and the safety of the immunogenicity of GX-G3.;Primary end point(s): The primary endpoints in the present trial are time to recover from severe neutropenia (defined as ANC <0.5x10^9/l) to a target =0.5x10^9/l after each administration of R-CHOP chemotherapy in cycles 1 and 2.;Timepoint(s) of evaluation of this end point: After conclusion of the clinical part of the trial and database lock.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: After conclusion of the clinical part of the trial and database lock.;<br> Secondary end point(s): - time to recover from severe neutropenia (defined as ANC <0.5x10^9/l) to a target =0.5x10^9/l after each administration of R-CHOP chemotherapy in cycles 1 and 2<br> - total duration of severe neutropenia in chemotherapy induction cycles 1 and 2<br> - time to recover from severe neutropenia (defined as ANC <0.5x10^9/l) to a target =1x10^9/l and =2x10^9/l after each administration of R-CHOP chemotherapy in cycles 1 and 2<br> - incidence of febrile neutropenia<br> - incidence of very severe neutropenia (defined as <0.1x10^9/l)<br> - incidence of infections<br>