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GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic

Phase 1

Leukaemia, Myelocytic, Acute | Monoclonal antibody | Oncology |GSK plc|Last Updated: Aug 7, 2018

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic · 1 trial · 1 indication

Phase 1 1
NCT00725283Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)Leukaemia, Myelocytic, Acute
COMPLETED34 Analytics
PHASE1COMPLETED
Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)
Leukaemia, Myelocytic, Acute
NCT0072528334
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Study Endpoints

Primary Endpoints

Number of Patients With Severe Toxicities
During the study treatment period (From Day 0 to Month 48)

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).

Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies
At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]

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).

Concentrations for Anti-WT1 Antibodies
At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]

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

Number of Patients With Anti-WT1 Antibody Response
At Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]

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.

Secondary Endpoints

Number of Patients With Any Unsolicited Adverse Events
Within the 31-day (Days 0-30) post-administration period
Number of Patients With Any Serious Adverse Events (SAEs)
During the whole study duration (From Day 0 up to the concluding visit, at Month 49)
Number of Patients With Serious Adverse Events Related to Study Treatment
During the whole study duration (From Day 0 up to the concluding visit, at Month 49)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK2130579A GroupEXPERIMENTALPatients 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.

Interventions

NameTypeDescription
GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI)BIOLOGICALIntramuscular administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * The patient has cytologically proven AML, as defined by the WHO classification. The pretreatment AML karyotype should be documented. * The leukemia could be a de novo or secondary AML. * The patient received induction and consolidation therapy according to the Institution's st...

Countries:United StatesFrance
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