Clinical trial · Interventional
Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is 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-positive AML presenting a suboptimal clinical response to induction chemotherapy. The study will also assess whether this treatment induces a specific immune response to the malignancy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukaemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Partial Remission Group
- description
- Adult 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.
- interventionNames
- Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A
- type
- EXPERIMENTAL
- label
- Complete Remission Group
- description
- Adult 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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, detected by quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR).The patient received the following therapy according to the Institution's standard of care. * For patients \< 60 years old: at least two induction chemotherapy treatments. * For patients \>= 60 years old: at least one induction chemotherapy treatment or alternative treatment. * The first ASCI administration should be given within one year after the last chemotherapy administration. All screening procedures should be completed within seven weeks before the first ASCI administration. * In the investigator's opinion and in compliance with the Institution Hematology Tumor Board's guidances, the patient should not be eligible for any additional chemotherapy treatment before the ASCI treatment. * The clinical status of the patient at inclusion is one of the following: * Partial Remission (PR) * Morphologic complete remission with incomplete blood count recovery (CRi) * Written informed consent has been obtained prior to the performance of any protocol-specific procedure. * The patient is \>= 18 years of age at the time of signature of the first informed consent form. * Eastern Cooperative Oncology Group performance status of 0, 1 or 2. * Adequate hepatic and renal function defined as: * Serum bilirubin \< 1.5 times the Upper Limit of Nor-mal (ULN). * Serum ALT \< 2.5 times the ULN. * Calculated creatinine clearance \> 50 mL/min. * In the view of the investigator, the patient can and will comply with the requirements of the protocol. * If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, then she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test and continue such precautions for 2 months after completion of the treatment administration series. Exclusion Criteria: * The patient was diagnosed with leukemic Central Nervous System (CNS) disease (e.g. before chemotherapy) or presents neurological symptoms at baseline suggestive of a CNS involvement. * The patient has acute promyelocytic leukemia with t(15;17) (q22;q12), (PML/RARα) or variants. * The patient has received, or is receiving, allogeneic Stem Cell Transplantation (SCT). * The patient has received Fludarabine, Clofarabine or Cloretazine within 12 months preceding the ASCI treat-ment. * The patient has hypercalcemia. * The patient is known to be HIV-positive. * The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease. Patients with vitiligo are not excluded. * The patient has a history of allergic reactions likely to be exacerbated by any component of the study investigational product. * The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. * The patient has another metastatic cancer disease. * The patient has a history of congestive heart failure, coronary artery disease or previous myocardial infarction. * The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures. * The patient has received any investigational or non-registered medicinal product other than the study treat-ment within 30 days preceding the first dose of study treatment or plans to receive such a drug during the study period. * The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents. * The patient is receiving full dose subcutaneous heparins or is under anti-coagulation treatment. * For female patients: the patient is pregnant or lactating.
References
Publications (0)
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