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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2014-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GRNVAC1

Autologous dendritic cell vaccine

Group Type EXPERIMENTAL

GRNVAC1

Intervention Type BIOLOGICAL

Autologous dendritic cell vaccine

Interventions

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GRNVAC1

Autologous dendritic cell vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No