A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
Primary Purpose
Acute Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GRNVAC1
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia
Eligibility Criteria
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
Sites / Locations
- Emory University School of Medicine
- Loyola University Medical Center
- Washington University School of Medicine, Siteman Cancer Center
- University of Nebraska Medical Center
- Ohio State University
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GRNVAC1
Arm Description
Autologous dendritic cell vaccine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00510133
First Posted
July 30, 2007
Last Updated
July 2, 2019
Sponsor
Asterias Biotherapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00510133
Brief Title
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asterias Biotherapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRNVAC1
Arm Type
Experimental
Arm Description
Autologous dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
GRNVAC1
Intervention Description
Autologous dendritic cell vaccine
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F DiPersio, MD,PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Washington University School of Medicine, Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.geron.com
Description
Related Info
Learn more about this trial
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
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