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

NCT02044276 | Completed Phase 3

• 2 other identifiers: XM22-ONC-3052013-001284-23
• Study Type: interventional
• Target: 101
• Locations: 3 countries
• Sites: 60

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.

Conditions

Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia

Keywords

Neutropenia; NHL; Non-Hodgkin lymphomas; R-CHOP-21

Outcome Measures

Primary Outcomes (1)

• Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L

  Grade 4 neutropenia measured in days

  3 weeks

Secondary Outcomes (6)

• Incidence of febrile neutropenia (FN) (strict definition)

  18 weeks

• Incidence of FN

  18 weeks

• Incidence of very severe neutropenia

  3 weeks

• Incidence of infections

  18 weeks

• Time to ANC recovery

  3 weeks

Study Arms (2)

lipegfilgrastim.

EXPERIMENTAL

subcutaneous (SC) injection of 6 mg lipegfilgrastim

Drug: lipegfilgrastim

pegfilgrastim

ACTIVE COMPARATOR

SC injection of 6 mg pegfilgrastim

Drug: pegfilgrastim

Interventions

lipegfilgrastim DRUG

6 mg

Also known as: XM22

lipegfilgrastim.

pegfilgrastim DRUG

6 mg

Also known as: Neulasta®

pegfilgrastim

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• Treatment with lithium at screening or planned during the study.
• Other Criteria apply, please contact the investigator for more information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (60)

Teva Investigational Site 32284

Aurich, 26603, Germany

Location

Teva Investigational Site 32314

Bad Soden am Taunus, 65812, Germany

Location

Teva Investigational Site 32267

Berlin, 10117, Germany

Location

Teva Investigational Site 32277

Berlin, 10707, Germany

Location

Teva Investigational Site 32292

Bochum, 44791, Germany

Location

Teva Investigational Site 32400

Bonn, 53105, Germany

Location

Teva Investigational Site 32318

Bonn, 53113, Germany

Location

Teva Investigational Site 32294

Bottrop, 46236, Germany

Location

Teva Investigational Site 32275

Cologne, 50674, Germany

Location

Teva Investigational Site 32282

Dresden, 01127, Germany

Location

Teva Investigational Site 32269

Dresden, 01307, Germany

Location

Teva Investigational Site 32303

Dresden, 01307, Germany

Location

Teva Investigational Site 32308

Frankfurt (Oder), 15236, Germany

Location

Teva Investigational Site 32302

Frankfurt-Hochst, 65929, Germany

Location

Teva Investigational Site 32276

Frechen, 50226, Germany

Location

Teva Investigational Site 32293

Freiburg im Breisgau, 79106, Germany

Location

Teva Investigational Site 32290

Freiburg im Breisgau, 79110, Germany

Location

Teva Investigational Site 32322

Fulda, 36043, Germany

Location

Teva Investigational Site 32320

Fürth, 90766, Germany

Location

Teva Investigational Site 32273

Goslar, 38642, Germany

Location

Teva Investigational Site 32296

Gütersloh, 33332, Germany

Location

Teva Investigational Site 32319

Halle, 06110, Germany

Location

Teva Investigational Site 32272

Hamburg, 22081, Germany

Location

Teva Investigational Site 32295

Heilbronn, 74078, Germany

Location

Teva Investigational Site 32270

Herne, 44623, Germany

Location

Teva Investigational Site 32401

Herne, 44625, Germany

Location

Teva Investigational Site 32279

Hof, 95028, Germany

Location

Teva Investigational Site 32297

Kaiserslautern, 67655, Germany

Location

Teva Investigational Site 32310

Kassel, 34119, Germany

Location

Teva Investigational Site 32280

Kiel, 24116, Germany

Location

Teva Investigational Site 32309

Krefeld, 47805, Germany

Location

Teva Investigational Site 32287

Lahr, 77933, Germany

Location

Teva Investigational Site 32289

Langen, 63225, Germany

Location

Teva Investigational Site 32313

Lebach, 66822, Germany

Location

Teva Investigational Site 32311

Leer, 26789, Germany

Location

Teva Investigational Site 32278

Leipzig, 04103, Germany

Location

Teva Investigational Site 32281

Mülheim, 45468, Germany

Location

Teva Investigational Site 32301

München, D-81377, Germany

Location

Teva Investigational Site 32274

Oldenburg, 26121, Germany

Location

Teva Investigational Site 32306

Pößneck, 07381, Germany

Location

Teva Investigational Site 32304

Ravensburg, 88212, Germany

Location

Teva Investigational Site 32291

Rotenburg (Wümme), 27356, Germany

Location

Teva Investigational Site 32315

Singen, 78224, Germany

Location

Teva Investigational Site 32300

Stade, 21680, Germany

Location

Teva Investigational Site 32288

Stolberg, 52222, Germany

Location

Teva Investigational Site 32268

Stuttgart, 70174, Germany

Location

Teva Investigational Site 32321

Stuttgart, 70376, Germany

Location

Teva Investigational Site 32305

Torgau, 04860, Germany

Location

Teva Investigational Site 32266

Villingen-Schwenningen, 78052, Germany

Location

Teva Investigational Site 32317

Villingen-Schwenningen, 78052, Germany

Location

Teva Investigational Site 32286

Weiden, 92637, Germany

Location

Teva Investigational Site 30061

Campobasso, 86100, Italy

Location

Teva Investigational Site 30059

Milan, 20162, Italy

Location

Teva Investigational Site 30063

Napoli, 80131, Italy

Location

Teva Investigational Site 30062

Torino, 10126, Italy

Location

Teva Investigational Site 31074

Barcelona, 08003, Spain

Location

Teva Investigational Site 31071

Madrid, 28006, Spain

Location

Teva Investigational Site 31070

Madrid, 28222, Spain

Location

Teva Investigational Site 31073

Valencia, 46010, Spain

Location

Teva Investigational Site 31072

Valencia, 46026, Spain

Location

Related Publications (1)

• Link H, Illerhaus G, Martens UM, Salar A, Depenbusch R, Kohler A, Engelhardt M, Mahlmann S, Zaiss M, Lammerich A, Bias P, Buchner A. Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study. Support Care Cancer. 2021 May;29(5):2519-2527. doi: 10.1007/s00520-020-05711-7. Epub 2020 Sep 17.

  PMID: 32944800 DERIVED

MeSH Terms

Conditions

Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: March 31, 2014
• Primary Completion: August 29, 2017
• Study Completion: April 24, 2018
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

DE (51); ES (5); IT (4)