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AVOID: 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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02044276
Collaborator
(none)
101
Enrollment
60
Locations
2
Arms
48.8
Actual Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 31, 2014
Actual Primary Completion Date :
Aug 29, 2017
Actual Study Completion Date :
Apr 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: lipegfilgrastim.

subcutaneous (SC) injection of 6 mg lipegfilgrastim

Drug: lipegfilgrastim
6 mg
Other Names:
  • XM22

    		•
    Active Comparator: pegfilgrastim

    SC injection of 6 mg pegfilgrastim

    Drug: pegfilgrastim
    6 mg
    Other Names:
  • Neulasta®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L [3 weeks]

      Grade 4 neutropenia measured in days

    Secondary Outcome Measures

    1. 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

    2. 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

    3. Incidence of very severe neutropenia [3 weeks]

      The occurrence of at least one incidence of ANC <0.1 * 10*9/L

    4. Incidence of infections [18 weeks]

      Incidence and severity of infections

    5. 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

    6. Summary of participants with adverse events [9 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 32284 Aurich Germany 26603
    2 Teva Investigational Site 32314 Bad Soden Am Taunus Germany 65812
    3 Teva Investigational Site 32267 Berlin Germany 10117
    4 Teva Investigational Site 32277 Berlin Germany 10707
    5 Teva Investigational Site 32292 Bochum Germany 44791
    6 Teva Investigational Site 32400 Bonn Germany 53105
    7 Teva Investigational Site 32318 Bonn Germany 53113
    8 Teva Investigational Site 32294 Bottrop Germany 46236
    9 Teva Investigational Site 32282 Dresden Germany 01127
    10 Teva Investigational Site 32269 Dresden Germany 01307
    11 Teva Investigational Site 32303 Dresden Germany 01307
    12 Teva Investigational Site 32308 Frankfurt (Oder) Germany 15236
    13 Teva Investigational Site 32302 Frankfurt-Hochst Germany 65929
    14 Teva Investigational Site 32276 Frechen Germany 50226
    15 Teva Investigational Site 32293 Freiburg Germany 79106
    16 Teva Investigational Site 32290 Freiburg Germany 79110
    17 Teva Investigational Site 32322 Fulda Germany 36043
    18 Teva Investigational Site 32320 Furth Germany 90766
    19 Teva Investigational Site 32273 Goslar Germany 38642
    20 Teva Investigational Site 32296 Gutersloh Germany 33332
    21 Teva Investigational Site 32319 Halle Germany 06110
    22 Teva Investigational Site 32272 Hamburg Germany 22081
    23 Teva Investigational Site 32295 Heilbronn Germany 74078
    24 Teva Investigational Site 32270 Herne Germany 44623
    25 Teva Investigational Site 32401 Herne Germany 44625
    26 Teva Investigational Site 32279 Hof Germany 95028
    27 Teva Investigational Site 32297 Kaiserslautern Germany 67655
    28 Teva Investigational Site 32310 Kassel Germany 34119
    29 Teva Investigational Site 32280 Kiel Germany 24116
    30 Teva Investigational Site 32275 Koeln Germany 50674
    31 Teva Investigational Site 32309 Krefeld Germany 47805
    32 Teva Investigational Site 32287 Lahr Germany 77933
    33 Teva Investigational Site 32289 Langen Germany 63225
    34 Teva Investigational Site 32313 Lebach Germany 66822
    35 Teva Investigational Site 32311 Leer Germany 26789
    36 Teva Investigational Site 32278 Leipzig Germany 04103
    37 Teva Investigational Site 32281 Mulheim Germany 45468
    38 Teva Investigational Site 32301 Munchen Germany D-81377
    39 Teva Investigational Site 32274 Oldenburg Germany 26121
    40 Teva Investigational Site 32306 Poessneck Germany 07381
    41 Teva Investigational Site 32304 Ravensburg Germany 88212
    42 Teva Investigational Site 32291 Rotenburg Germany 27356
    43 Teva Investigational Site 32315 Singen Germany 78224
    44 Teva Investigational Site 32300 Stade Germany 21680
    45 Teva Investigational Site 32288 Stolberg Germany 52222
    46 Teva Investigational Site 32268 Stuttgart Germany 70174
    47 Teva Investigational Site 32321 Stuttgart Germany 70376
    48 Teva Investigational Site 32305 Torgau Germany 04860
    49 Teva Investigational Site 32266 Villingen- Schwenningen Germany 78052
    50 Teva Investigational Site 32317 Villingen-Schwenningen Germany 78052
    51 Teva Investigational Site 32286 Weiden Germany 92637
    52 Teva Investigational Site 30061 Campobasso Italy 86100
    53 Teva Investigational Site 30059 Milano Italy 20162
    54 Teva Investigational Site 30063 Napoli Italy 80131
    55 Teva Investigational Site 30062 Torino Italy 10126
    56 Teva Investigational Site 31074 Barcelona Spain 08003
    57 Teva Investigational Site 31071 Madrid Spain 28006
    58 Teva Investigational Site 31070 Madrid Spain 28222
    59 Teva Investigational Site 31073 Valencia Spain 46010
    60 Teva Investigational Site 31072 Valencia Spain 46026

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT02044276
    Other Study ID Numbers:
    • XM22-ONC-305
    • 2013-001284-23
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.
    Neutropenia
    NHL
    Non-Hodgkin lymphomas
    R-CHOP-21
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Lymphoma, B-Cell
    Neutropenia
    Aggression

    Study Results

    No Results Posted as of Jun 8, 2022