Recent Updates
Recently added Catalysts

GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic GSK2130579A

Phase 1

Leukaemia, Myelocytic, Acute | Monoclonal antibody | Oncology |GSK plc|Last Updated: Nov 29, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic GSK2130579A · 1 trial · 1 indication

Phase 1 1
NCT01051063Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction ChemotherapyLeukaemia, Myelocytic, Acute
COMPLETED17 Analytics
PHASE1COMPLETED
Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
Leukaemia, Myelocytic, AcuteUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With Severe Toxicities
During the entire study (from Month 0 to Month 49)

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: study product-related or possibly study product-related 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). * 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).

Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)
During the entire study (from Month 0 to Month 49)

CR = having \< 5% blasts in aspirate sample with marrow spicules and with a count of ≥ 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease; different phenotype (by flow cytometry) to the pre-treatment specimen; absolute neutrophil count \> 1000/mm3; platelet count ≥ 100 000/mm3 and being independent of red blood cell (RBC) transfusions. PR = a decrease of ≤ 50% in the % of blasts in bone marrow aspirate compared to Visit 4; being independent of RBC transfusions and the absolute neutrophil ≥ 1000/mm3 and platelet counts and ≥ 100 000/mm3. SD = no sufficient criteria for CR, a PR or Progressive disease (PD = Reappearance of leukemic blasts in the peripheral blood; Reappearance/development of cytologically proven extramedullary disease, Appearance of new dysplastic changes, or in a bone marrow aspirate sample (with marrow spicules and with a count of ≥200 nucleated cells) of ≥5% blasts; or, in case of early progression, a higher blast % than at Visit 4).

Secondary Endpoints

Anti-WT1 Seropositivity Rate
At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4
Anti-WT1 Antibody Concentrations
At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4
Anti-WT1 Antibody Response
At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Partial Remission GroupEXPERIMENTALAdult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Complete Remission GroupEXPERIMENTALAdult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.

Interventions

NameTypeDescription
GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579ABIOLOGICALIntramuscular injection
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * The patient has cytologically proven AML as defined by the World Health Organization (WHO) classification. The pretreatment AML karyotype should be documented. * The leukemia is a de novo or secondary AML. * The patient's blasts cells show expression of WT1 transcript, detecte...

Countries:United StatesFranceGermany
Unlock Eligibility Criteria