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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510133
• Other study ID #: GRNVAC1 CP06-151
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: August 2014

Study information

• Verified date: July 2019
• Source: Asterias Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• GRNVAC1
Autologous dendritic cell vaccine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Asterias Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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