A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    grnvac1 ...
  • Study Participants

This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
This is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in patients with AML in complete clinical remission. Patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy. Dendritic cells will be transfected with the messenger RNA encoding human telomerase reverse transcriptase (hTERT) and a portion of the lysosome-associated membrane protein LAMP-1 (LAMP), matured, aliquoted, and cryopreserved. The final autologous vaccine product is referred to as GRNVAC1. Patients will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6 boost injections, each administered every other week for 12 weeks. Patients will be followed every 4 weeks until Week 54, then every 3 months for 1 year, then every 6 months up to approximately 5 years from the first vaccination or until relapse/progression.
Study Started
Jul 31
Primary Completion
Dec 31
Study Completion
Aug 31
Last Update
Jul 09

Biological GRNVAC1

Autologous dendritic cell vaccine

GRNVAC1 Experimental

Autologous dendritic cell vaccine


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/renal function

Exclusion Criteria:

CR1 and good risk cytogenetic features [t(15;17), t(8;21), inv(16) or t(16:16)]
Central nervous system or leptomeningeal disease
Allogeneic stem cell transplant planned or expected
Documented allergy to penicillin or beta-lactam antibiotics
Active or ongoing autoimmune disease
Clinically significant pulmonary or cardiovascular disease
No Results Posted