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

Phase 1

• Conditions: 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: 16.0Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001284-23-ES
• Lead Sponsor: Merckle GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified