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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725283
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukaemia, Myelocytic, Acute Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia
Study Start Date : October 2008
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Group A
Patients received 24 doses of the study treatment over a period of approximately 4 years
Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A
Intramuscular administration
Other Name: WT1 ASCI

Primary Outcome Measures :
  1. Occurrence of severe toxicities as defined in the protocol [ Time Frame: During the study treatment period ]
  2. Humoral and cellular Immunogenicity of the WT1 ASCI [ Time Frame: At 21 defined timepoints during the whole study including the follow-up period ]

Secondary Outcome Measures :
  1. Occurrence of adverse events and serious adverse events [ Time Frame: During study treatment period, ending 30 days after the last study treatment administration ]
  2. Occurrence of serious adverse events related to study treatment [ Time Frame: During the whole study duration ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 standard of care.
  • The patient's blasts cells show expression of WT1 tran-script, detected by quantitative RT-PCR.
  • The patient is in complete remission (i.e. CR1, CR2, …):
  • 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 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 alanine aminotransferase < 2.5 times the ULN.
    • Calculated creatinine clearance > 50 mL/min.
  • 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, she must practice adequate con-traception for 30 days prior to treatment administration, have a negative pregnancy test and continue such pre-cautions for two months after completion of the treatment administration series.
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

  • The patient is in morphologic leukemia-free state or in morphologic complete remission with incomplete blood count recovery (CRi).
  • The patient has acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) or variants.
  • The patient has received, or is receiving induction chemotherapy followed by Stem Cell Transplantation.
  • The patient has (or has had) previous or concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
  • 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.
  • 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 a history of congestive heart failure, cor-onary 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 medi-cation within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.
  • The patient requires concomitant treatment with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.
  • The patient has received intravenous administration of antibiotics within 2 weeks prior to first study treatment or oral antibiotics within 1 week prior to first study treatment.
  • For female patients: the patient is pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725283

United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33612
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14263
GSK Investigational Site
New York, New York, United States, 10032
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157-1009
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98109-1023
GSK Investigational Site
Grenoble cedex 9, France, 38043
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00725283     History of Changes
Other Study ID Numbers: 111444
2010-023886-24 ( EudraCT Number )
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by GlaxoSmithKline:
Complete remission
Acute Myeloid Leukemia
Tumor antigen

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type