Trial record 19 of 139 for:    Open Studies | "Aggression"

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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Teva Pharmaceutical Industries
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Merckle GmbH )
ClinicalTrials.gov Identifier:
NCT02044276
First received: January 21, 2014
Last updated: August 25, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Grade 4 neutropenia measured in days


Secondary Outcome Measures:
  • Incidence of febrile neutropenia (FN) (strict definition) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Body temperature of >38.5°C for at least one hour and ANC<1*10^9/L

  • Incidence of FN [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The occurrence of at least one incidence of ANC <0.1 * 10*9/L

  • Incidence of infections [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Incidence and severity of infections

  • Time to ANC recovery [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044276

Contacts
Contact: Teva US Medical Information 1-800-896-5855

  Show 68 Study Locations
Sponsors and Collaborators
Merckle GmbH
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Merckle GmbH )
ClinicalTrials.gov Identifier: NCT02044276     History of Changes
Other Study ID Numbers: XM22-ONC-305, 2013-001284-23
Study First Received: January 21, 2014
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
Spain: Ministry of Health

Keywords provided by Teva Pharmaceutical Industries:
Neutropenia
NHL
Non-Hodgkin lymphomas
R-CHOP-21

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

ClinicalTrials.gov processed this record on August 28, 2014