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

Sponsor
Asterias Biotherapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00510133
Collaborator
(none)
21
Enrollment
6
Locations
1
Arm
85
Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.

Condition or Disease Intervention/Treatment Phase
  • Biological: GRNVAC1
 Phase 2

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: GRNVAC1

Autologous dendritic cell vaccine

Biological: GRNVAC1
Autologous dendritic cell vaccine

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emory University School of Medicine Atlanta Georgia United States 30322
2 Loyola University Medical Center Maywood Illinois United States 60153
3 Washington University School of Medicine, Siteman Cancer Center Saint Louis Missouri United States 63110
4 University of Nebraska Medical Center Omaha Nebraska United States 68198
5 Ohio State University Columbus Ohio United States 43210
6 UT Southwestern Medical Center Dallas Texas United States 75390

Sponsors and Collaborators

  • Asterias Biotherapeutics, Inc.

Investigators

  • Principal Investigator: John F DiPersio, MD,PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00510133
Other Study ID Numbers:
  • GRNVAC1 CP06-151
First Posted:
Aug 1, 2007
Last Update Posted:
Jul 9, 2019
Last Verified:
Jul 1, 2019
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jul 9, 2019