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Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy

2014-08-27 03:16:34 | BioPortfolio

Summary

This study is being done to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult patients with WT1-postivie Acute Myeloid Leukemia and with a suboptimal clinical response to induction chemotherapy. It will also be analyzed to what extent this treatment induces a specific immune response specific to the malignancy.

This protocol posting has been updated following Protocol amendment 1, Sep 2009.

Description

At least 40 patients will be enrolled in this study, divided in two cohorts of 20 patients each. One cohort will include patients in partial remission after induction therapy and one cohort will include patients in complete remission but with incomplete blood count recovery. Patients in both cohorts will receive the same study treatment according to the same administration schedule.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

WT1-positive Acute Myeloid Leukemia

Intervention

GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A

Location

GSK Investigational Site
Nashville
Tennessee
United States
37232

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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