A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
- Conditions
- Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
- Interventions
- Registration Number
- NCT02044276
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
-
Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
-
Age ≥65 years and ≤85 years
-
Histological documentation of aggressive B cell NHL
-
Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
-
ECOG score ≤2
-
Life expectancy of at least 3 months
-
Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy
-
The patient is capable of understanding and complying with parameters as outlined in the protocol
-
Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug.
-
The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study
- Other Criteria apply, please contact the investigator for more information
-
Participation in a clinical study within 30 days before randomization
-
Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed.
-
The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
-
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
-
Active cardiac disease
-
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.
-
Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
-
Patients with evidence or history of bleeding diathesis.
-
Non-healing wound, ulcer or bone fracture.
-
Renal failure requiring hemo- or peritoneal dialysis.
-
Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
-
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
-
Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
-
Treatment with lithium at screening or planned during the study.
- Other Criteria apply, please contact the investigator for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lipegfilgrastim. lipegfilgrastim subcutaneous (SC) injection of 6 mg lipegfilgrastim pegfilgrastim pegfilgrastim SC injection of 6 mg pegfilgrastim
- Primary Outcome Measures
Name Time Method Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L 3 weeks Grade 4 neutropenia measured in days
- Secondary Outcome Measures
Name Time Method Incidence of FN 18 weeks A single temperature of ≥38.3°C or ≥38.0°C for at least one hour and ANC \<1 \* 10\^9/L
Incidence of febrile neutropenia (FN) (strict definition) 18 weeks Body temperature of \>38.5°C for at least one hour and ANC\<1\*10\^9/L
Incidence of very severe neutropenia 3 weeks The occurrence of at least one incidence of ANC \<0.1 \* 10\*9/L
Incidence of infections 18 weeks Incidence and severity of infections
Summary of participants with adverse events 9 Months Time to ANC recovery 3 weeks The time in days from start of chemotherapy administration until the ANC increases to ≥1.0 x 109/L, ≥1.5 x 109/L, and ≥2.0 x 109/L after the expected nadir
Trial Locations
- Locations (60)
Teva Investigational Site 30059
🇮🇹Milano, Italy
Teva Investigational Site 32275
🇩🇪Koeln, Germany
Teva Investigational Site 32284
🇩🇪Aurich, Germany
Teva Investigational Site 32267
🇩🇪Berlin, Germany
Teva Investigational Site 32314
🇩🇪Bad Soden Am Taunus, Germany
Teva Investigational Site 32277
🇩🇪Berlin, Germany
Teva Investigational Site 32318
🇩🇪Bonn, Germany
Teva Investigational Site 32319
🇩🇪Halle, Germany
Teva Investigational Site 32309
🇩🇪Krefeld, Germany
Teva Investigational Site 32287
🇩🇪Lahr, Germany
Teva Investigational Site 32289
🇩🇪Langen, Germany
Teva Investigational Site 32281
🇩🇪Mulheim, Germany
Teva Investigational Site 32313
🇩🇪Lebach, Germany
Teva Investigational Site 32274
🇩🇪Oldenburg, Germany
Teva Investigational Site 32311
🇩🇪Leer, Germany
Teva Investigational Site 32301
🇩🇪Munchen, Germany
Teva Investigational Site 32317
🇩🇪Villingen-Schwenningen, Germany
Teva Investigational Site 30063
🇮🇹Napoli, Italy
Teva Investigational Site 30062
🇮🇹Torino, Italy
Teva Investigational Site 31074
🇪🇸Barcelona, Spain
Teva Investigational Site 31071
🇪🇸Madrid, Spain
Teva Investigational Site 32400
🇩🇪Bonn, Germany
Teva Investigational Site 32292
🇩🇪Bochum, Germany
Teva Investigational Site 32294
🇩🇪Bottrop, Germany
Teva Investigational Site 32303
🇩🇪Dresden, Germany
Teva Investigational Site 32308
🇩🇪Frankfurt (Oder), Germany
Teva Investigational Site 32320
🇩🇪Furth, Germany
Teva Investigational Site 32272
🇩🇪Hamburg, Germany
Teva Investigational Site 32273
🇩🇪Goslar, Germany
Teva Investigational Site 32280
🇩🇪Kiel, Germany
Teva Investigational Site 32278
🇩🇪Leipzig, Germany
Teva Investigational Site 32306
🇩🇪Poessneck, Germany
Teva Investigational Site 32282
🇩🇪Dresden, Germany
Teva Investigational Site 32269
🇩🇪Dresden, Germany
Teva Investigational Site 32276
🇩🇪Frechen, Germany
Teva Investigational Site 32302
🇩🇪Frankfurt-Hochst, Germany
Teva Investigational Site 32290
🇩🇪Freiburg, Germany
Teva Investigational Site 32322
🇩🇪Fulda, Germany
Teva Investigational Site 32293
🇩🇪Freiburg, Germany
Teva Investigational Site 32296
🇩🇪Gutersloh, Germany
Teva Investigational Site 32279
🇩🇪Hof, Germany
Teva Investigational Site 32401
🇩🇪Herne, Germany
Teva Investigational Site 32310
🇩🇪Kassel, Germany
Teva Investigational Site 32297
🇩🇪Kaiserslautern, Germany
Teva Investigational Site 32304
🇩🇪Ravensburg, Germany
Teva Investigational Site 32291
🇩🇪Rotenburg, Germany
Teva Investigational Site 32300
🇩🇪Stade, Germany
Teva Investigational Site 32315
🇩🇪Singen, Germany
Teva Investigational Site 32268
🇩🇪Stuttgart, Germany
Teva Investigational Site 32305
🇩🇪Torgau, Germany
Teva Investigational Site 32321
🇩🇪Stuttgart, Germany
Teva Investigational Site 32266
🇩🇪Villingen- Schwenningen, Germany
Teva Investigational Site 30061
🇮🇹Campobasso, Italy
Teva Investigational Site 32286
🇩🇪Weiden, Germany
Teva Investigational Site 31070
🇪🇸Madrid, Spain
Teva Investigational Site 31072
🇪🇸Valencia, Spain
Teva Investigational Site 31073
🇪🇸Valencia, Spain
Teva Investigational Site 32295
🇩🇪Heilbronn, Germany
Teva Investigational Site 32270
🇩🇪Herne, Germany
Teva Investigational Site 32288
🇩🇪Stolberg, Germany