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

Phase 3

Completed

• Conditions: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
• Interventions: Drug: lipegfilgrastim; Drug: pegfilgrastim

• Registration Number: NCT02044276
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-03-31
• Primary Completion: 2017-08-29
• Study Completion: 2018-04-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lipegfilgrastim.	lipegfilgrastim	subcutaneous (SC) injection of 6 mg lipegfilgrastim
pegfilgrastim	pegfilgrastim	SC injection of 6 mg pegfilgrastim

Primary Outcome Measures

Name	Time	Method
Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L	3 weeks	Grade 4 neutropenia measured in days

Secondary Outcome Measures

Name	Time	Method
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
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
Incidence of very severe neutropenia	3 weeks	The occurrence of at least one incidence of ANC \<0.1 \* 10\*9/L
Incidence of infections	18 weeks	Incidence and severity of infections
Summary of participants with adverse events	9 Months
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

Trial Locations

Locations (60)

Teva Investigational Site 32284; 🇩🇪 Aurich, Germany

Teva Investigational Site 32314; 🇩🇪 Bad Soden Am Taunus, Germany

Teva Investigational Site 32267; 🇩🇪 Berlin, Germany

Teva Investigational Site 32277; 🇩🇪 Berlin, Germany

Teva Investigational Site 32292; 🇩🇪 Bochum, Germany

Teva Investigational Site 32400; 🇩🇪 Bonn, Germany

Teva Investigational Site 32318; 🇩🇪 Bonn, Germany

Teva Investigational Site 32294; 🇩🇪 Bottrop, Germany

Teva Investigational Site 32282; 🇩🇪 Dresden, Germany

Teva Investigational Site 32269; 🇩🇪 Dresden, Germany

Scroll for more (50 remaining)