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)
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| ClinicalTrials.gov Identifier: NCT02044276 |
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Recruitment Status :
Completed
First Posted : January 23, 2014
Last Update Posted : May 25, 2018
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Sponsor:
Merckle GmbH
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Merckle GmbH )
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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.
| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 101 participants |
| 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 |
| Actual Study Start Date : | March 31, 2014 |
| Actual Primary Completion Date : | August 29, 2017 |
| Actual Study Completion Date : | April 24, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cyclic neutropenia
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Pegfilgrastim
| Arm | Intervention/treatment |
|---|---|
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Experimental: lipegfilgrastim.
subcutaneous (SC) injection of 6 mg lipegfilgrastim
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Drug: lipegfilgrastim
6 mg
Other Name: XM22 |
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Active Comparator: pegfilgrastim
SC injection of 6 mg pegfilgrastim
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Drug: pegfilgrastim
6 mg
Other Name: Neulasta® |
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 ]
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| Ages Eligible for Study: | 65 Years to 85 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
- Age ≥65 years and ≤85 years
- Histological documentation of aggressive B cell NHL
- Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
- ECOG score ≤2
- Life expectancy of at least 3 months
- Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy
- The patient is capable of understanding and complying with parameters as outlined in the protocol
- 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.
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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:
- Participation in a clinical study within 30 days before randomization
- 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.
- The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
- Active cardiac disease
- 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.
- Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
- Patients with evidence or history of bleeding diathesis.
- Non-healing wound, ulcer or bone fracture.
- Renal failure requiring hemo- or peritoneal dialysis.
- Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
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Treatment with lithium at screening or planned during the study.
- Other Criteria apply, please contact the investigator for more information
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
Locations
Show 45 study locations
Sponsors and Collaborators
Merckle GmbH
Investigators
| Study Director: | Teva Medical Expert, MD | Teva Pharmaceuticals USA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merckle GmbH |
| ClinicalTrials.gov Identifier: | NCT02044276 |
| Other Study ID Numbers: |
XM22-ONC-305 2013-001284-23 ( EudraCT Number ) |
| First Posted: | January 23, 2014 Key Record Dates |
| Last Update Posted: | May 25, 2018 |
| Last Verified: | May 2018 |
| 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 ):
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Neutropenia NHL Non-Hodgkin lymphomas R-CHOP-21 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neutropenia Aggression Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Behavioral Symptoms Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |