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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02044276
First Posted: January 23, 2014
Last Update Posted: August 31, 2017
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Merckle GmbH )
  Purpose
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 Intervention Phase
Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia Drug: lipegfilgrastim Drug: pegfilgrastim Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Merckle GmbH ):

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


Secondary Outcome Measures:
  • 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

  • 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

  • Incidence of very severe neutropenia [ Time Frame: 3 weeks ]
    The occurrence of at least one incidence of ANC <0.1 * 10*9/L

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

  • 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

  • Summary of participants with adverse events [ Time Frame: 9 Months ]

Enrollment: 101
Actual Study Start Date: March 31, 2014
Estimated Study Completion Date: May 16, 2018
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02044276


  Show 53 Study Locations
Sponsors and Collaborators
Merckle GmbH
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Merckle GmbH
ClinicalTrials.gov Identifier: NCT02044276     History of Changes
Other Study ID Numbers: XM22-ONC-305
2013-001284-23 ( EudraCT Number )
First Submitted: January 21, 2014
First Posted: January 23, 2014
Last Update Posted: August 31, 2017
Last Verified: August 2017

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 ):
Neutropenia
NHL
Non-Hodgkin lymphomas
R-CHOP-21

Additional relevant MeSH terms:
Neutropenia
Lymphoma
Lymphoma, Non-Hodgkin
Aggression
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases