Acute Myelogenous Leukemia Clinical Trial
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
Verified date | July 2019 |
Source | Asterias Biotherapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
Status | Completed |
Enrollment | 21 |
Est. completion date | August 2014 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | Ohio State University | Columbus | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Washington University School of Medicine, Siteman Cancer Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Asterias Biotherapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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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