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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Acute Myelogenous Leukemia

Intervention / Treatment
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* Biological: GRNVAC1


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRNVAC1<br>Autologous dendritic cell vaccine | Biological: GRNVAC1<br>* Autologous dendritic cell vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |