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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia

Thank you

Trial Information

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 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 lyosome-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.


Inclusion Criteria:



- AML in first CR or in CR2 with CR1 >/= 6 months

- Has completed at least one cycle of consolidation chemotherapy within past 6 months

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John F DiPersio, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

GRNVAC1 CP06-151

NCT ID:

NCT00510133

Start Date:

July 2007

Completion Date:

February 2015

Related Keywords:

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

Name

Location
Loyola University Medical Center Maywood, Illinois  60153
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Emory University School of Medicine Atlanta, Georgia  30322
Ohio State University Columbus, Ohio  43210
Ut Southwestern Medical Center Dallas, Texas  75390
Washington University School of Medicine, Siteman Cancer Center St. Louis, Missouri  63110