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.

Study Overview

• Status: Completed
• Conditions: Acute Myelogenous Leukemia
• Intervention / Treatment: Biological: GRNVAC1

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine, Siteman Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRNVAC1; Autologous dendritic cell vaccine	Biological: GRNVAC1; Autologous dendritic cell vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Asterias Biotherapeutics, Inc.
• Investigators: Principal Investigator: John F DiPersio, MD,PhD, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 30, 2007
• First Submitted That Met QC Criteria: July 30, 2007
• First Posted (Estimate): August 1, 2007

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: GRNVAC1 CP06-151