Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005831

Trial Description

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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

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Trial Acronym

AVOID

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005831
  •   2014/11/26
  •   2014/01/21
  •   no
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Secondary IDs

  •   2013-001284-23 
  •   NCT02044276  (ClinicalTrials.gov)
  •   XM22-ONC-305  (Merckle GmbH)
  •   2013-001284-23 
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Health Condition or Problem studied

  •   Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
  •   C85.1 -  B-cell lymphoma, unspecified
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Interventions/Observational Groups

  •   Drug: lipegfilgrastim
  •   Drug: pegfilgrastim
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L; time frame: 3 weeks; Grade 4 neutropenia measured in days

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
  •   Italy
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2014/02/27
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   85   Years
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Additional 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

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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

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Addresses

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    • Merckle GmbH
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    • Teva US Medical Information 
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    •   1-800-896-5855
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    • Teva US Medical Information 
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    •   1-800-896-5855
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   81
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.