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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 May 2018 |
Main ID: |
EUCTR2013-001284-23-ES |
Date of registration:
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08/10/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A randomized, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with aggressive B cell Non-HOdgkin lymphomas at hIgh risk for R-CHOP-21-inDuced neutropenia ? AVOID Neutropenia
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Scientific title:
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A randomized, phase IIIB, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with aggressive B cell Non-HOdgkin lymphomas at hIgh risk for R-CHOP-21-inDuced neutropenia ? AVOID Neutropenia - AVOID Neutropenia |
Date of first enrolment:
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21/11/2013 |
Target sample size:
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150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001284-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Italy
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Spain
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Contacts
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Name:
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Clinical Operations
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Address:
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Hanferstraße 28
79108
Freiburg
Germany |
Telephone:
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00497611524231 |
Email:
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judith.mueller@iomedico.com |
Affiliation:
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iOMEDICO AG |
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Name:
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Clinical Operations
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Address:
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Hanferstraße 28
79108
Freiburg
Germany |
Telephone:
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00497611524231 |
Email:
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judith.mueller@iomedico.com |
Affiliation:
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iOMEDICO AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: a. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent b. Age ?65 years and ?85 years c. Histological documentation of aggressive B cell NHL d. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards e. ECOG score ?2 f. Life expectancy of at least 3 months g. Adequate bone marrow, renal and hepatic function as evidenced by the following within 14 days before start of chemotherapy: -absolute neutrophil count (ANC) ?1.5 x 109/L -platelets ?100 x 109/L -hemoglobin ?9.0 g/dL -serum creatinine ?1.5 x upper limit of the normal range (ULN) OR glomerular filtration rate (GFR) ?30 mL/minute/1.73 m2 -Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5 x ULN; bilirubin ?1.5 x ULN; alkaline phosphatase limit ?2.5 x ULN h. The patient is capable of understanding and complying with parameters as outlined in the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria: a. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy. b. Active cardiac disease including any of the following: -Congestive heart failure >New York Heart Association (NYHA) class 2. -Unstable angina, new-onset angina, myocardial infarction less than 6 months before start of chemotherapy. -Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). -Uncontrolled hypertension. c. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy. d. Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C. e. Patients with evidence or history of bleeding diathesis. f. Non-healing wound, ulcer or bone fracture. g. Renal failure requiring hemo- or peritoneal dialysis. h. Any conditions that may interfere with the patient?s participation in the study or evaluation of the study results. i. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. j. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study. k. Treatment with lithium at screening or planned during the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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The study population includes patients with aggressive B cell Non-Hodgkin Lymphoma (NHL) planned to receive systemic anti-cancer therapy with at least 6 cycles of R-CHOP-21, according to local standards. MedDRA version: 16.0
Level: LLT
Classification code 10066481
Term: Hematological malignancy
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Lonquex Product Name: Lonquex Product Code: XM22 Pharmaceutical Form: Solution for injection INN or Proposed INN: lipegfilgrastim CAS Number: 1117844-87-7 Current Sponsor code: XM22 Other descriptive name: GlycoPEGylated r-metHuG-CSF Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Trade Name: Neulasta® Product Name: pegfilgrastim Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGFILGRASTIM CAS Number: 208265-92-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to demonstrate non-inferiority of lipegfilgrastim (Lonquex, Teva) vs. pegfilgrastim (Neulasta®, Amgen) for the duration of severe neutropenia (DSN) in the first cycle of chemotherapy.
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Secondary Objective: -To compare efficacy of lipegfilgrastim and pegfilgrastim in elderly patients with B cell NHL receiving chemotherapy with R-CHOP-21 throughout the study. -To compare safety and tolerability of lipegfilgrastim and pegfilgrastim in elderly patients with B cell NHL receiving chemotherapy with R-CHOP-21 throughout the study. -To assess incidence and severity of infections throughout the study. -To compare effect of lipegfilgrastim and pegfilgrastim treatment on quality of life. -To further characterize exposure-response relationships for lipegfilgrastim. -To further characterize the immunogenicity of lipegfilgrastim.
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Primary end point(s): The primary endpoint for this study is the duration of severe neutropenia in days in the first cycle of chemotherapy.
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Timepoint(s) of evaluation of this end point: days 1, 3, 5, 8, 10, 12, 15
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Daily temperature measurement; ANC assessment days 1, 3, 5, 8, 10, 12, 15 in cycle one and days 1, 8, 15 in all other cycles
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Secondary end point(s): - Incidence of febrile neutropenia (FN) by cycle and across all cycles - Incidence of severe/very severe neutropenia in Cycle 1 - Depth of ANC nadir in Cycle 1 - Proportion of patients with severe neutropenia lasting <1 day, <2 days, <3 days, or ?3 days in Cycle 1 - Time to ANC recovery in first treatment cycle - Incidence and severity of infections. - Time in hospital and time in intensive care unit due to all causes and due to FN or connected infections. - Incidence of hospitalizations by cycle due to FN. - Incidence of treatment with IV and oral antibiotics due to FN or connected infections. - Percentage of actually delivered vs. scheduled cumulative chemotherapy dose. - Proportion of patients with chemotherapy doses reduced, omitted, or delayed.
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Secondary ID(s)
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2013-001284-23-DE
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XM22-ONC-305
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Source(s) of Monetary Support
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Merckle GmbH
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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