Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
Conditions
Keywords
Neutropenia, NHL, Non-Hodgkin lymphomas, R-CHOP-21
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.
Interventions
DRUGlipegfilgrastim
6 mg
DRUGpegfilgrastim
6 mg
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
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 (Any woman becoming pregnant during the study will be withdrawn from the study.) 4.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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L | 3 weeks | Grade 4 neutropenia measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 very severe neutropenia | 3 weeks | The occurrence of at least one incidence of ANC \<0.1 \* 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 |
| 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 |
| Summary of participants with adverse events | 9 Months | — |
| Incidence of infections | 18 weeks | Incidence and severity of infections |
Countries
Germany, Italy, Spain
Outcome results
None listed