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Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients in First Complete Remission


Phase 1
18 Years
N/A
Open (Enrolling)
Both
WT1-positive Acute Myeloid Leukemia, Leukaemia, Myelocytic, Acute

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Trial Information

Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients in First Complete Remission


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of severe toxicities as defined in the protocol

Outcome Time Frame:

During the study treatment period

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

111444

NCT ID:

NCT00725283

Start Date:

October 2008

Completion Date:

September 2017

Related Keywords:

  • WT1-positive Acute Myeloid Leukemia
  • Leukaemia, Myelocytic, Acute
  • Leukemia
  • ASCI
  • Complete remission
  • Immunotherapy
  • adult
  • Tumor antigen
  • WT1
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021