Clinical trial NCT02044276: 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
Official title: A Randomized, Phase IIIB, Open-label, Two-arm, Multicenter, comparatiVe Study on Efficacy and Safety of Lipegfilgrastim (Lonquex, TEVA) in Comparison to Pegfilgrastim (Neulasta(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
Keywords: Neutropenia
NHL
Non-Hodgkin lymphomas
R-CHOP-21
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
2. Age ≥65 years and ≤85 years
3. Histological documentation of aggressive B cell NHL
4. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
5. ECOG score ≤2
6. Life expectancy of at least 3 months
7. Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy
8. The patient is capable of understanding and complying with parameters as outlined in the protocol
9. 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.
10. 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

Exclusion Criteria:

1. Participation in a clinical study within 30 days before randomization
2. 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.
3. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
5. Active cardiac disease
6. 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.
7. Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
8. Patients with evidence or history of bleeding diathesis.
9. Non-healing wound, ulcer or bone fracture.
10. Renal failure requiring hemo- or peritoneal dialysis.
11. Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
12. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
13. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
14. Treatment with lithium at screening or planned during the study.

    * Other Criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L
timeFrame: 3 weeks
Secondary outcomes:
measure: Incidence of febrile neutropenia (FN) (strict definition)
timeFrame: 18 weeks
measure: Incidence of FN
timeFrame: 18 weeks
measure: Incidence of very severe neutropenia
timeFrame: 3 weeks
measure: Incidence of infections
timeFrame: 18 weeks
measure: Time to ANC recovery
timeFrame: 3 weeks
measure: Summary of participants with adverse events
timeFrame: 9 Months
Other outcomes:
Locations:
city: Aurich
country: Germany
facility: Teva Investigational Site 32284
city: Bad Soden Am Taunus
country: Germany
facility: Teva Investigational Site 32314
city: Berlin
country: Germany
facility: Teva Investigational Site 32267
city: Berlin
country: Germany
facility: Teva Investigational Site 32277
city: Bochum
country: Germany
facility: Teva Investigational Site 32292
city: Bonn
country: Germany
facility: Teva Investigational Site 32400
city: Bonn
country: Germany
facility: Teva Investigational Site 32318
city: Bottrop
country: Germany
facility: Teva Investigational Site 32294
city: Dresden
country: Germany
facility: Teva Investigational Site 32282
city: Dresden
country: Germany
facility: Teva Investigational Site 32269
city: Dresden
country: Germany
facility: Teva Investigational Site 32303
city: Frankfurt (Oder)
country: Germany
facility: Teva Investigational Site 32308
city: Frankfurt-Hochst
country: Germany
facility: Teva Investigational Site 32302
city: Frechen
country: Germany
facility: Teva Investigational Site 32276
city: Freiburg
country: Germany
facility: Teva Investigational Site 32293
city: Freiburg
country: Germany
facility: Teva Investigational Site 32290
city: Fulda
country: Germany
facility: Teva Investigational Site 32322
city: Furth
country: Germany
facility: Teva Investigational Site 32320
city: Goslar
country: Germany
facility: Teva Investigational Site 32273
city: Gutersloh
country: Germany
facility: Teva Investigational Site 32296
city: Halle
country: Germany
facility: Teva Investigational Site 32319
city: Hamburg
country: Germany
facility: Teva Investigational Site 32272
city: Heilbronn
country: Germany
facility: Teva Investigational Site 32295
city: Herne
country: Germany
facility: Teva Investigational Site 32270
city: Herne
country: Germany
facility: Teva Investigational Site 32401
city: Hof
country: Germany
facility: Teva Investigational Site 32279
city: Kaiserslautern
country: Germany
facility: Teva Investigational Site 32297
city: Kassel
country: Germany
facility: Teva Investigational Site 32310
city: Kiel
country: Germany
facility: Teva Investigational Site 32280
city: Koeln
country: Germany
facility: Teva Investigational Site 32275
city: Krefeld
country: Germany
facility: Teva Investigational Site 32309
city: Lahr
country: Germany
facility: Teva Investigational Site 32287
city: Langen
country: Germany
facility: Teva Investigational Site 32289
city: Lebach
country: Germany
facility: Teva Investigational Site 32313
city: Leer
country: Germany
facility: Teva Investigational Site 32311
city: Leipzig
country: Germany
facility: Teva Investigational Site 32278
city: Mulheim
country: Germany
facility: Teva Investigational Site 32281
city: Munchen
country: Germany
facility: Teva Investigational Site 32301
city: Oldenburg
country: Germany
facility: Teva Investigational Site 32274
city: Poessneck
country: Germany
facility: Teva Investigational Site 32306
city: Ravensburg
country: Germany
facility: Teva Investigational Site 32304
city: Rotenburg
country: Germany
facility: Teva Investigational Site 32291
city: Singen
country: Germany
facility: Teva Investigational Site 32315
city: Stade
country: Germany
facility: Teva Investigational Site 32300
city: Stolberg
country: Germany
facility: Teva Investigational Site 32288
city: Stuttgart
country: Germany
facility: Teva Investigational Site 32268
city: Stuttgart
country: Germany
facility: Teva Investigational Site 32321
city: Torgau
country: Germany
facility: Teva Investigational Site 32305
city: Villingen- Schwenningen
country: Germany
facility: Teva Investigational Site 32266
city: Villingen-Schwenningen
country: Germany
facility: Teva Investigational Site 32317
city: Weiden
country: Germany
facility: Teva Investigational Site 32286
city: Campobasso
country: Italy
facility: Teva Investigational Site 30061
city: Milano
country: Italy
facility: Teva Investigational Site 30059
city: Napoli
country: Italy
facility: Teva Investigational Site 30063
city: Torino
country: Italy
facility: Teva Investigational Site 30062
city: Barcelona
country: Spain
facility: Teva Investigational Site 31074
city: Madrid
country: Spain
facility: Teva Investigational Site 31071
city: Madrid
country: Spain
facility: Teva Investigational Site 31070
city: Valencia
country: Spain
facility: Teva Investigational Site 31073
city: Valencia
country: Spain
facility: Teva Investigational Site 31072
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: Link H, Illerhaus G, Martens UM, Salar A, Depenbusch R, Kohler A, Engelhardt M, Mahlmann S, Zaiss M, Lammerich A, Bias P, Buchner A. Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study. Support Care Cancer. 2021 May;29(5):2519-2527. doi: 10.1007/s00520-020-05711-7. Epub 2020 Sep 17.