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liposomal cytarabine

Phase 2

Primary Disease | Small molecule | Other |Amgen Inc.|Last Updated: Mar 3, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Clinical trial landscape

liposomal cytarabine · 1 trial · 1 indication

Phase 2 1
NCT01325194CHemoImmunotherapy With Early Central Nervous System (CNS) ProphylaxisPrimary Disease
COMPLETED143 Analytics
PHASE2COMPLETED
CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis
Primary Disease
NCT01325194143
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Study Endpoints

Primary Endpoints

Time to treatment failure
3 and 5 years

Secondary Endpoints

Maximal hematological, gastrointestinal, neuronal and other toxicities
Treatment period (5 years)
Clinical response rate
Treatment period (5 years)
Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases
3 and 5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CNS prophylaxisEXPERIMENTAL -

Interventions

NameTypeDescription
liposomal cytarabineDRUG50 mg intrathecally three times
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Age ≥ 18 - \< 65 years. Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) based on WHO 2008 Lymphoma Classification * Follicular lymphomas (FLs) grade 3b is allowed Patients in at least stage II with age adjusted international prognostic score (IPI score) o...

Countries:DenmarkFinlandNorwaySweden
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Frequently asked questions about liposomal cytarabine

What is liposomal cytarabine used for?

Liposomal cytarabine is an investigational small molecule being studied for the treatment of primary disease. It is currently in Phase 2 clinical development. The drug is being evaluated in a completed clinical trial that enrolled 143 participants.

Who is developing liposomal cytarabine?

Liposomal cytarabine is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development for the treatment of primary disease.

What phase is liposomal cytarabine in?

Liposomal cytarabine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.

What clinical trials is liposomal cytarabine in?

Liposomal cytarabine has been studied in one clinical trial with the identifier NCT01325194, titled "CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis." This Phase 2 trial was completed and enrolled 143 participants across Denmark, Finland, Norway, and Sweden.

Is liposomal cytarabine the same as cytarabine?

Liposomal cytarabine is a formulation of the chemotherapy drug cytarabine, where the drug is encapsulated in liposomes. This formulation is being studied for its potential use in treating primary disease and is currently in Phase 2 clinical development.