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

NCT ID: NCT02044276

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-04-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lipegfilgrastim.

subcutaneous (SC) injection of 6 mg lipegfilgrastim

Group Type: EXPERIMENTAL

lipegfilgrastim

Intervention Type: DRUG

6 mg

pegfilgrastim

SC injection of 6 mg pegfilgrastim

Group Type: ACTIVE_COMPARATOR

pegfilgrastim

Intervention Type: DRUG

6 mg

Interventions

lipegfilgrastim

6 mg

Intervention Type: DRUG

pegfilgrastim

6 mg

Intervention Type: DRUG

Other Intervention Names

XM22; Neulasta®

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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 32275

Cologne, , Germany

Teva Investigational Site 32282

Dresden, , Germany

Teva Investigational Site 32269

Dresden, , Germany

Teva Investigational Site 32303

Dresden, , Germany

Teva Investigational Site 32308

Frankfurt (Oder), , Germany

Teva Investigational Site 32302

Frankfurt-Hochst, , Germany

Teva Investigational Site 32276

Frechen, , Germany

Teva Investigational Site 32293

Freiburg im Breisgau, , Germany

Teva Investigational Site 32290

Freiburg im Breisgau, , Germany

Teva Investigational Site 32322

Fulda, , Germany

Teva Investigational Site 32320

Fürth, , Germany

Teva Investigational Site 32273

Goslar, , Germany

Teva Investigational Site 32296

Gütersloh, , Germany

Teva Investigational Site 32319

Halle, , Germany

Teva Investigational Site 32272

Hamburg, , Germany

Teva Investigational Site 32295

Heilbronn, , Germany

Teva Investigational Site 32270

Herne, , Germany

Teva Investigational Site 32401

Herne, , Germany

Teva Investigational Site 32279

Hof, , Germany

Teva Investigational Site 32297

Kaiserslautern, , Germany

Teva Investigational Site 32310

Kassel, , Germany

Teva Investigational Site 32280

Kiel, , Germany

Teva Investigational Site 32309

Krefeld, , Germany

Teva Investigational Site 32287

Lahr, , Germany

Teva Investigational Site 32289

Langen, , Germany

Teva Investigational Site 32313

Lebach, , Germany

Teva Investigational Site 32311

Leer, , Germany

Teva Investigational Site 32278

Leipzig, , Germany

Teva Investigational Site 32281

Mülheim, , Germany

Teva Investigational Site 32301

München, , Germany

Teva Investigational Site 32274

Oldenburg, , Germany

Teva Investigational Site 32306

Pößneck, , Germany

Teva Investigational Site 32304

Ravensburg, , Germany

Teva Investigational Site 32291

Rotenburg (Wümme), , Germany

Teva Investigational Site 32315

Singen, , Germany

Teva Investigational Site 32300

Stade, , Germany

Teva Investigational Site 32288

Stolberg, , Germany

Teva Investigational Site 32268

Stuttgart, , Germany

Teva Investigational Site 32321

Stuttgart, , Germany

Teva Investigational Site 32305

Torgau, , Germany

Teva Investigational Site 32266

Villingen-Schwenningen, , Germany

Teva Investigational Site 32317

Villingen-Schwenningen, , Germany

Teva Investigational Site 32286

Weiden, , Germany

Teva Investigational Site 30061

Campobasso, , Italy

Teva Investigational Site 30059

Milan, , Italy

Teva Investigational Site 30063

Napoli, , Italy

Teva Investigational Site 30062

Torino, , Italy

Teva Investigational Site 31074

Barcelona, , Spain

Teva Investigational Site 31071

Madrid, , Spain

Teva Investigational Site 31070

Madrid, , Spain

Teva Investigational Site 31073

Valencia, , Spain

Teva Investigational Site 31072

Valencia, , Spain

Countries

Germany; Italy; Spain

References

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.

Reference Type: DERIVED

PMID: 32944800 (View on PubMed)

Other Identifiers

2013-001284-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XM22-ONC-305

Identifier Type: -

Identifier Source: org_study_id