Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced NeutropeniaPhase 3AVOIDNCT02044276

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

A Phase 3 study testing lipegfilgrastim and pegfilgrastim in people with Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia, run by Teva Branded Pharmaceutical Products R&D, Inc. at 60 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
What is being tested?: lipegfilgrastim and pegfilgrastim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 60 sitesin 3 countries
Study dates: 31 Mar 2014to 24 Apr 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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

Trial locations and contacts

60 sites in 3 countries.

Country

City, postcode or hospital

60 sites in 3 countries

Germany51 sites

Teva Investigational Site 32284
Aurich, 26603
Teva Investigational Site 32314
Bad Soden am Taunus, 65812
Teva Investigational Site 32267
Berlin, 10117
Teva Investigational Site 32277
Berlin, 10707
Teva Investigational Site 32292
Bochum, 44791
Teva Investigational Site 32400
Bonn, 53105
Teva Investigational Site 32318
Bonn, 53113
Teva Investigational Site 32294
Bottrop, 46236
Teva Investigational Site 32275
Cologne, 50674
Teva Investigational Site 32282
Dresden, 01127
Teva Investigational Site 32269
Dresden, 01307
Teva Investigational Site 32303
Dresden, 01307
Teva Investigational Site 32308
Frankfurt (Oder), 15236
Teva Investigational Site 32302
Frankfurt-Hochst, 65929
Teva Investigational Site 32276
Frechen, 50226
Teva Investigational Site 32293
Freiburg im Breisgau, 79106
Teva Investigational Site 32290
Freiburg im Breisgau, 79110
Teva Investigational Site 32322
Fulda, 36043
Teva Investigational Site 32320
Fürth, 90766
Teva Investigational Site 32273
Goslar, 38642
Teva Investigational Site 32296
Gütersloh, 33332
Teva Investigational Site 32319
Halle, 06110
Teva Investigational Site 32272
Hamburg, 22081
Teva Investigational Site 32295
Heilbronn, 74078
Teva Investigational Site 32270
Herne, 44623
Teva Investigational Site 32401
Herne, 44625
Teva Investigational Site 32279
Hof, 95028
Teva Investigational Site 32297
Kaiserslautern, 67655
Teva Investigational Site 32310
Kassel, 34119
Teva Investigational Site 32280
Kiel, 24116
Teva Investigational Site 32309
Krefeld, 47805
Teva Investigational Site 32287
Lahr, 77933
Teva Investigational Site 32289
Langen, 63225
Teva Investigational Site 32313
Lebach, 66822
Teva Investigational Site 32311
Leer, 26789
Teva Investigational Site 32278
Leipzig, 04103
Teva Investigational Site 32281
Mülheim, 45468
Teva Investigational Site 32301
München, D-81377
Teva Investigational Site 32274
Oldenburg, 26121
Teva Investigational Site 32306
Pößneck, 07381
Teva Investigational Site 32304
Ravensburg, 88212
Teva Investigational Site 32291
Rotenburg (Wümme), 27356
Teva Investigational Site 32315
Singen, 78224
Teva Investigational Site 32300
Stade, 21680
Teva Investigational Site 32288
Stolberg, 52222
Teva Investigational Site 32268
Stuttgart, 70174
Teva Investigational Site 32321
Stuttgart, 70376
Teva Investigational Site 32305
Torgau, 04860
Teva Investigational Site 32266
Villingen-Schwenningen, 78052
Teva Investigational Site 32317
Villingen-Schwenningen, 78052
Teva Investigational Site 32286
Weiden, 92637

Other trials in Germany

Spain5 sites

Teva Investigational Site 31074
Barcelona, 08003
Teva Investigational Site 31071
Madrid, 28006
Teva Investigational Site 31070
Madrid, 28222
Teva Investigational Site 31073
Valencia, 46010
Teva Investigational Site 31072
Valencia, 46026

Other trials in Spain

Italy4 sites

Teva Investigational Site 30061
Campobasso, 86100
Teva Investigational Site 30059
Milan, 20162
Teva Investigational Site 30063
Naples, 80131
Teva Investigational Site 30062
Torino, 10126

Other trials in Italy

About this study

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(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia

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
Being tested: lipegfilgrastim, pegfilgrastim
Keywords: Neutropenia, NHL, Non-Hodgkin lymphomas, R-CHOP-21
Medical subject headings: Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lipegfilgrastimDrug
Also called XM22
6 mg
pegfilgrastimDrug
Also called Neulasta®
6 mg

Study groups in NCT02044276
Study group	Role	What they receive
lipegfilgrastim.	Experimental	subcutaneous (SC) injection of 6 mg lipegfilgrastim Receives: Drug: lipegfilgrastim
pegfilgrastim	Active comparator	SC injection of 6 mg pegfilgrastim Receives: Drug: pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Incidence of febrile neutropenia (FN) (strict definition)
Body temperature of >38.5°C for at least one hour and ANC<1*10^9/L
Measured: 18 weeks
Incidence of FN
A single temperature of ≥38.3°C or ≥38.0°C for at least one hour and ANC <1 * 10^9/L
Measured: 18 weeks
Incidence of very severe neutropenia
The occurrence of at least one incidence of ANC <0.1 * 10*9/L
Measured: 3 weeks
Incidence of infections
Incidence and severity of infections
Measured: 18 weeks
Time to ANC recovery
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
Measured: 3 weeks
Summary of participants with adverse events
Measured: 9 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 201424 Apr 2018

First posted23 Jan 2014 (estimated)
Study start31 Mar 2014
Primary completion29 Aug 2017
Study completion24 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced NeutropeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02044276
Sponsor's protocol ID: XM22-ONC-305
Other IDs: 2013-001284-23
Acronym: AVOID
Status last verified: Jun 2022
First submitted: 21 Jan 2014
Last updated: 8 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32944800

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia
ClinicalTrials.gov ID: NCT02044276
Acronym / sponsor ID: AVOID / XM22-ONC-305
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 31 Mar 2014 (actual)
Primary completion: 29 Aug 2017 (actual)
Study completion: 24 Apr 2018 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
lipegfilgrastim.	Experimental	Drug: lipegfilgrastimsubcutaneous (SC) injection of 6 mg lipegfilgrastim
pegfilgrastim	Active comparator	Drug: pegfilgrastimSC injection of 6 mg pegfilgrastim

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lipegfilgrastimAlso: XM226 mg	Drug	lipegfilgrastim.
pegfilgrastimAlso: Neulasta®6 mg	Drug	pegfilgrastim

Primary outcome

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

6 secondary outcomes

Incidence of febrile neutropenia (FN) (strict definition)
Time frame: 18 weeks
Incidence of FN
Time frame: 18 weeks
Incidence of very severe neutropenia
Time frame: 3 weeks
Incidence of infections
Time frame: 18 weeks
Time to ANC recovery
Time frame: 3 weeks
Summary of participants with adverse events
Time frame: 9 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Derived from this study: PubMed 32944800Link 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

60 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Germany, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.