Status:
COMPLETED
Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Myelocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00725283
Start Date
October 1 2008
End Date
June 22 2016
Last Update
August 7 2018
Active Locations (10)
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1
GSK Investigational Site
Tampa, Florida, United States, 33612
2
GSK Investigational Site
Baltimore, Maryland, United States, 21201
3
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
4
GSK Investigational Site
Buffalo, New York, United States, 14263