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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00725283
First received: July 29, 2008
Last updated: March 6, 2014
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients in First Complete Remission

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of severe toxicities as defined in the protocol [ Time Frame: During the study treatment period ] [ Designated as safety issue: No ]
  • Humoral and cellular Immunogenicity of the WT1 ASCI [ Time Frame: At 21 defined timepoints during the whole study including the follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse events and serious adverse events [ Time Frame: During study treatment period, ending 30 days after the last study treatment administration ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events related to study treatment [ Time Frame: During the whole study including the follow-up period ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: October 2008
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2130579A
i.m. administration
Other Name: WT1 ASCI

Detailed Description:

This protocol posting has been updated according to Protocol amendment on the 05th Jan 09.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has cytologically proven AML, as defined by the WHO classification. The pretreatment AML karyotype should be documented. Patients with acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) and variants should be excluded.
  2. The leukemia could be a de novo or secondary AML.
  3. The patient received induction and consolidation therapy according to the Institution's standard of care.
  4. The patient's blasts cells show expression of WT1 transcript, detected by quantitative RT-PCR.
  5. The patient is in first morphologic complete remission (CR1):
  6. Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
  7. The patient is ≥ 18 years of age at the time of signature of the informed consent form.
  8. Eastern Cooperative Oncology Group performance status of 0, 1 or 2 at the time of enrolment.
  9. Adequate hepatic and renal function defined as:

    • Serum bilirubin < 1.5 times the Upper Limit of Normal (ULN).
    • Serum ALT < 2.5 times the ULN.
    • Calculated creatinine clearance > 50 ml/min.
  10. 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 contraception for 30 days prior to treatment administration, have a negative pregnancy test and continue such precautions for two months after completion of the treatment administration series.
  11. In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

  1. The patient is in morphologic leukemia-free state or in morphologic complete remission with incomplete blood count recovery (CRi) as defined by "Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia"[Cheson 2003].
  2. The patient has acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) or variants.
  3. The patient has received, is receiving -or is due to receive- induction chemotherapy followed by Stem Cell Transplantation.
  4. 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.
  5. The patient has hypercalcemia.
  6. The patient is known to be HIV-positive.
  7. The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease.
  8. The patient has a history of allergic reactions likely to be exacerbated by any component of the study investigational product.
  9. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  10. The patient has a history of congestive heart failure, coronary artery disease or previous myocardial infarction.
  11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  12. The patient has received any investigational or non-registered medicinal product other than the study medication within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.
  13. The patient requires concomitant treatment with systemic corticosteroids or any 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.
  14. 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.
  15. For female patients: the patient is pregnant or lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725283

Locations
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
France
GSK Investigational Site
Grenoble cedex 9, France, 38043
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00725283     History of Changes
Other Study ID Numbers: 111444
Study First Received: July 29, 2008
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Leukemia
ASCI
Complete remission
Immunotherapy
adult
Tumor antigen
WT1

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

ClinicalTrials.gov processed this record on October 01, 2014