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

Asterias Biotherapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia

Treatments: Biological: GRNVAC1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510133

GRNVAC1 CP06-151

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

GRNVAC1

Experimental group

Description:

Autologous dendritic cell vaccine

Treatment:

Biological: GRNVAC1