A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00510133
First received: July 30, 2007
Last updated: August 11, 2014
Last verified: August 2014

July 30, 2007
August 11, 2014
July 2007
December 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00510133 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Immunolgical 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. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
Biological: GRNVAC1
Autologous dendritic cell vaccine
Experimental: GRNVAC1
Autologous dendritic cell vaccine
Intervention: Biological: GRNVAC1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2014
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510133
GRNVAC1 CP06-151
No
Asterias Biotherapeutics, Inc.
Asterias Biotherapeutics, Inc.
Not Provided
Principal Investigator: John F DiPersio, MD,PhD Washington University School of Medicine
Asterias Biotherapeutics, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP