NCT00510133

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00510133

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

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

Eligibility

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

Disease(s) and\or Condition(s)

Acute Myelogenous Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: GRNVAC1
- Description: Autologous dendritic cell vaccine
- Arm Group Labels: GRNVAC1

Sponsor

Asterias Biotherapeutics, Inc.