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plerixafor GZ316455

Phase 2

Lymphoma | Small molecule | Oncology |Sanofi|Last Updated: Mar 30, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

plerixafor GZ316455 · 2 trials · 2 indications

Phase 2 2
NCT02221492Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin LymphomaLymphoma
COMPLETED32 Analytics
NCT02221479Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple MyelomaMultiple Myeloma
COMPLETED14 Analytics
PHASE2COMPLETED
Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma
LymphomaUnlock trial analytics
PHASE2COMPLETED
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period

Secondary Endpoints

Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
granulocyte colony-stimulating factor aloneACTIVE_COMPARATORG-CSF administered up to 8 days
granulocyte colony-stimulating factor plus plerixaforEXPERIMENTALG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
Granulocyte colony-stimulating factor (G-CSF) aloneACTIVE_COMPARATORG-CSF administered up to 8 days
G-CSF plus plerixaforEXPERIMENTALG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)

Interventions

NameTypeDescription
plerixafor GZ316455DRUGPharmaceutical form:vial Route of administration: subcutaneous injection
FilgrastimDRUGPharmaceutical form:vial Route of administration: subcutaneous injection
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: * Age 20 to 75. * Japanese participants with histological or pathological diagnosis of NHL. * First or second complete response (CR) or partial response (PR). Exclusion criteria: * Leukemia participants. * Myelodysplastic syndrome (MDS) participants. * Less than 2 weeks since ...

Countries:Japan
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Competitive Landscape -Lymphoma 338 trials

Top 20 of 66 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
AstraZeneca PLCAZN14PHASE3Surovatamig, R-CHOP, R-CVP, BR
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles, Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC20PHASE3BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide
Bristol-Myers Squibb CompanyBMY17PHASE3Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Johnson & JohnsonJNJ11PHASE3Ibrutinib
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
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Frequently asked questions about plerixafor GZ316455

What is plerixafor GZ316455 used for?

Plerixafor GZ316455 is an investigational small molecule being studied for use in lymphoma and multiple myeloma. It is being developed to mobilize and collect peripheral hematopoietic stem cells in patients with these conditions, typically in combination with granulocyte colony-stimulating factor (G-CSF).

Who makes plerixafor GZ316455?

Plerixafor GZ316455 is being developed by Sanofi, a company traded under the ticker SNY. The drug is currently in Phase 2 clinical development for oncology indications including lymphoma and multiple myeloma.

What phase is plerixafor GZ316455 in?

Plerixafor GZ316455 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for this drug have been completed, with no active trials currently ongoing.

What clinical trials is plerixafor GZ316455 in?

Plerixafor GZ316455 has been studied in two completed Phase 2 clinical trials in Japan. NCT02221479 enrolled 14 participants with multiple myeloma, and NCT02221492 enrolled 32 participants with non-Hodgkin lymphoma. Both trials evaluated plerixafor plus G-CSF for stem cell mobilization and collection.

Is plerixafor GZ316455 the same as plerixafor?

Plerixafor GZ316455 is a form of plerixafor, a small molecule being developed by Sanofi. It is being studied for stem cell mobilization in patients with lymphoma and multiple myeloma, and has completed Phase 2 trials in Japan.