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Trial record 1 of 2 for:    AVOID Lipegfilgrastim
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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 (AVOID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02044276
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : May 25, 2018
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Merckle GmbH )

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
Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia Drug: lipegfilgrastim Drug: pegfilgrastim Phase 3

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Study Type : Interventional  (Clinical Trial)
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®, 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 : March 31, 2014
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : April 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: lipegfilgrastim.
subcutaneous (SC) injection of 6 mg lipegfilgrastim
Drug: lipegfilgrastim
6 mg
Other Name: XM22

Active Comparator: pegfilgrastim
SC injection of 6 mg pegfilgrastim
Drug: pegfilgrastim
6 mg
Other Name: Neulasta®

Primary Outcome Measures :
  1. Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L [ Time Frame: 3 weeks ]
    Grade 4 neutropenia measured in days

Secondary Outcome Measures :
  1. Incidence of febrile neutropenia (FN) (strict definition) [ Time Frame: 18 weeks ]
    Body temperature of >38.5°C for at least one hour and ANC<1*10^9/L

  2. Incidence of FN [ Time Frame: 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 [ Time Frame: 3 weeks ]
    The occurrence of at least one incidence of ANC <0.1 * 10*9/L

  4. Incidence of infections [ Time Frame: 18 weeks ]
    Incidence and severity of infections

  5. Time to ANC recovery [ Time Frame: 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 [ Time Frame: 9 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02044276

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Sponsors and Collaborators
Merckle GmbH
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merckle GmbH Identifier: NCT02044276    
Other Study ID Numbers: XM22-ONC-305
2013-001284-23 ( EudraCT Number )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Pharmaceutical Industries ( Merckle GmbH ):
Non-Hodgkin lymphomas
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Leukocyte Disorders
Hematologic Diseases