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lipegfilgrastim

Phase 3

Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Jun 8, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

lipegfilgrastim · 3 trials · 4 indications

Phase 3 1Phase 1 2
NCT02044276A 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 NeutropeniaAggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
COMPLETED101 Analytics
PHASE3COMPLETED
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
Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
NCT02044276101
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Study Endpoints

Primary Endpoints

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

Grade 4 neutropenia measured in days

PK: Area under the serum concentration-time curve (AUC), from time 0 to the last measurable concentration (AUC0-t)
Days 1-8, 10, 14, 17, 21

2 hours for visits 3, 9; 1 day for visit 10

AUC from time 0 extrapolated to infinity (AUC0-∞)
Days 1-8, 10, 14, 17, 21
Maximum observed serum drug concentration (Cmax)
Days 1-8, 10, 14, 17, 21
Time to maximum observed serum drug concentration (tmax)
Days 1-8, 10, 14, 17, 21
The percentage of the extrapolated area to infinity in relation to the total area under the curve (%AUCext)
Visits 3, 9, 10
Apparent serum terminal elimination rate constant (λz)
Days 1-8, 10, 14, 17, 21

2 hours for visits 3, 9; 1 day for visit 10

Associated elimination half-life (t½)
Days 1-8, 10, 14, 17, 21
Mean residence time (MRT)
Days 1-8, 10, 14, 17, 21
Apparent total body clearance (CL/F)
Days 1-8, 10, 14, 17, 21
Apparent volume of distribution during the terminal phase (Vz/F)
Days 1-8, 10, 14, 17, 21
PD: ANC area over baseline effect curve (ANC AOBEC)
Days 1-8, 10, 14, 17, 21
Maximum measured ANC value after dosing (ANC Cmax)
Days 1-8, 10, 14, 17, 21
Time point at which ANC Cmax is observed (ANC tmax)
Days 1-8, 10, 14, 17, 21
Time (days) until ANC returns to baseline value
Days 1-8, 10, 14, 17, 21
CD34+ area over the baseline effect curve (CD34+ AOBEC)
Days 1-8, 10, 14, 17, 21
Maximum measured CD34+ value after dosing (CD34+ Cmax)
Days 1-8, 10, 14, 17, 21
Time point at which CD34+ Cmax is observed (CD34+ tmax)
Days 1-8, 10, 14, 17, 21
PK: Area under the curve, Maximum observed serum concentration (Cmax), Rate constant associated with terminal phase, Mean Residence Time, Time to reach Cmax, and Apparent volume of distribution during terminal phase after non-intravenous administration
16 months

A total of 7 PK samples will be obtained at prespecified periods

Secondary Endpoints

Incidence of febrile neutropenia (FN) (strict definition)
18 weeks
Incidence of FN
18 weeks
Incidence of very severe neutropenia
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
lipegfilgrastim.EXPERIMENTALsubcutaneous (SC) injection of 6 mg lipegfilgrastim
pegfilgrastimACTIVE_COMPARATORSC injection of 6 mg pegfilgrastim
lipegfilgrastim 30EXPERIMENTAL -
lipegfilgrastim 60EXPERIMENTAL -
lipegfilgrastim 100EXPERIMENTAL -
XM22, 100 μg/kg BWEXPERIMENTAL -

Interventions

NameTypeDescription
lipegfilgrastimDRUG6 mg
pegfilgrastimDRUG6 mg
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Eligibility Criteria

Age Range65 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites60

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 loca...

Countries:GermanyItalySpainUnited KingdomBulgariaCzechiaHungaryPolandRussiaUkraine
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Frequently asked questions about lipegfilgrastim

What is Lipegfilgrastim used for?

Lipegfilgrastim is an investigational oncology drug being studied for use in Ewing Family of Tumors, Rhabdomyosarcoma, and Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia. It is also being studied for pharmacokinetics and pharmacodynamics in healthy participants.

Who makes Lipegfilgrastim?

Lipegfilgrastim is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.

What phase is Lipegfilgrastim in?

Lipegfilgrastim is in clinical development. It has completed Phase 1 and Phase 3 trials, and is currently listed as being in Phase 1. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Lipegfilgrastim in?

Lipegfilgrastim has completed three clinical trials: NCT01585649, a Phase 1 PK/PD study in children with Ewing Family of Tumors or Rhabdomyosarcoma; NCT02044276, a Phase 3 comparative study in elderly patients with aggressive B cell non-Hodgkin lymphomas; and NCT02306915, a Phase 1 study in healthy Japanese and Caucasian participants.

Is Lipegfilgrastim the same as XM22?

Lipegfilgrastim is also known as XM22, as referenced in the clinical trial NCT01585649, which is titled 'PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma'. Both names refer to the same investigational drug.