Acute Myelogenous Leukemia
Conditions
Brief summary
This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
Detailed 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.
Interventions
BIOLOGICALGRNVAC1
Autologous dendritic cell vaccine
Sponsors
Asterias Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed