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GRNVAC1

Phase 2

Acute Myelogenous Leukemia | Monoclonal antibody | Oncology |Lineage Cell Therapeutics, Inc.|Last Updated: Jul 9, 2019

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical trial landscape

GRNVAC1 · 1 trial · 1 indication

Phase 2 1
NCT00510133A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)Acute Myelogenous Leukemia
COMPLETED21 Analytics
PHASE2COMPLETED
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
Acute Myelogenous Leukemia
NCT0051013321
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Study Endpoints
Primary Endpoints
Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
1 year
Secondary Endpoints
Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival.
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GRNVAC1EXPERIMENTALAutologous dendritic cell vaccine
Interventions
NameTypeDescription
GRNVAC1BIOLOGICALAutologous dendritic cell vaccine
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 \>/= 6 months * Has completed at least one cycle of consolidation chemotherapy within past 6 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hepatic/ren...

Countries:United States
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