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Diseases and Abnormalities at or Before Birth

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Wilms Tumor

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Hematologic Diseases

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Immunomodulating Agents

Patients with cytologically proven AML, as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years.

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

GSK Clinical Trials

This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.

In this study, patients were to receive a maximum of 24 doses of WT1 ASCI according four cycles over a period of four years.

This protocol summary has been updated according to the Protocol Amendment 6 (dated 10 Sept 2014).

There will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end 30 days after the last dose will be administered, so the patients will not be further exposed to unnecessary study related procedures.. In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant. Blood sampling for safety monitoring as per protocol will continue.

Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)

Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia

Severe toxicities (as classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related:

* Grade 4 toxicity (exception: Grade 4 fatigue - including lethargy, asthenia, and malaise - had to have a duration of at least 48 hours to be taken into account).
* Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration).
* An allergic reaction/hypersensitivity Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition.
* Decrease in renal function, with a calculated creatinine clearance \< 40 mL/min.
* Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina).

Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).

Treatment response was defined as:

For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Serious adverse events (SAEs) assessed include any medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the Clinical Report Form (CRF), but not as an SAE.

Serious adverse events (SAEs) assessed include medical occurrences related to treatment administration that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.

GlaxoSmithKline

Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).

GSK2130579A Group

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

GSK Response Center

Encephalitis

Rash erythematous

Hypersensitivity

Angina pectoris

Rash

Thrombocytopenia

This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.

Number of Patients With Severe Toxicities

Week 0

Week 5

Week 9

Week 13

Week 15

Week 21

Week 32

Week 40

Week 54

Month 15

Month 18

Month 21

Month 24

Month 30

Month 49

Month 52

Month 55

Month 58

Month 61

This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.

Spots Global Cancer Trial Database for Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)

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