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

Completed · Phase 1

Conditions studied: Leukaemia, Myelocytic, Acute

In brief

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.

Key facts

Study ID

NCT01051063

Run by

GlaxoSmithKline

People needed

17

Starts

2009-12-09

Expected to finish

2016-04-26

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Worcester, Massachusetts, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Angers, France
• GSK Investigational Site — Grenoble, France
• GSK Investigational Site — Lille, France
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Nantes, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Pessac, France
• GSK Investigational Site — Pierre-Bénite, France
• GSK Investigational Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• GSK Investigational Site — Heidelberg, Baden-Wurttemberg, Germany
• GSK Investigational Site — Ulm, Baden-Wurttemberg, Germany
• GSK Investigational Site — Erlangen, Bavaria, Germany
• GSK Investigational Site — Würzburg, Bavaria, Germany
• GSK Investigational Site — Oldenburg, Lower Saxony, Germany
• GSK Investigational Site — Rostock, Mecklenburg-Vorpommern, Germany
• GSK Investigational Site — Münster, North Rhine-Westphalia, Germany
• GSK Investigational Site — Mainz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Berlin, Germany

Full record on ClinicalTrials.gov

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