Status:
UNKNOWN
Safety and Immunogenicity of Recombinant WT1 Antigen-Specific Cancer Immunotherapeutic Combined With Infusion of Treg Depleted T Cells for Adult WT1 Acute Myeloid Leukemia
Lead Sponsor:
Jules Bordet Institute
Conditions:
Acute Myelogenous Leukemia
Myeloid Leukemia in Remission
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of combined treatment strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in vivo regulatory T c...
Detailed Description
High-risk and intermediate-high risk CR1 AML patients who are not eligible for allo-SCT after chemotherapy have an unfavorable prognosis, and there is currently no treatment able to improve their surv...
Eligibility Criteria
Inclusion
- The patient has cytologically proven AML, as defined by the WHO classification. The leukemia is a de novo or a secondary leukemia.
- The patient is in complete morphologic remission Note: Cytogenetic CR (CRc) or molecular CR (CRm) is not required.
- AML patients in first complete remission (CR1) who are not eligible for allo-HSCT following the institution's standard of care(except the favourable genetic group subset which is excluded from this study).
- All AML patients in second or third complete morphological remission(CR2 or CR3) who are not eligible for allo-HSCT.
- The patient received the following therapy according to the institution's standard of care:
- For patients ≤ 60 years old, at least two cycles of intensive chemotherapy (induction and consolidation)
- For patients \> 60 years old, at least one induction chemotherapy. Any patients with severe co-morbidity for which consolidation is unacceptable, can receive only one induction therapy.
- The patient's blasts cells show over-expression of WT1 transcripts, detected in peripheral blood by qRT-PCR at diagnosis or at first relapse.
- 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 signing of the ICF.
- ECOG performance status of 0, 1, or 2 at the time of enrollment.
- Adequate hepatic and renal function defined as:
- Serum bilirubin \< 1.5 times the Upper Limit of Normal (ULN).
- Serum alanine aminotransferase ALAT \< 2.5 times the ULN.
- Calculated creatinine clearance \> 40 mL/min.
- If the patient is female, then 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 two months after completion of the treatment administration series.
- Under the investigator criteria, the patient is able to comply with the protocol requirements during the duration of the study.
- In the investigator's opinion and in compliance with the Institution hematology guidance, the patient should not be eligible for an approved standard of care such as induction with chemotherapy or allo-HSCT.
Exclusion
- The patient is in morphologic leukemia-free state or in morphologic complete remission but with incomplete blood count recovery as defined by IWG Response Criteria
- The patient is in CR1 and is in the category of low-risk for relapse patients, i.e. belong to the favourable genetic group subset .
- 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 received, is receiving (or is due to receive) allo-HSCT.
- The patient has (or has had) concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
- The patient is known to be human immunodeficiency virus (HIV)-positive.
- The patient has symptomatic autoimmune disease such as, but not limited to, multiple sclerosis, lupus, rheumatoid arthritis and inflammatory 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 problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- The patient has congestive heart failure, symptomatic 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 medication 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), inhaled corticosteroids or topical steroids is permitted.
- The patient has an active infection and/or is receiving antibiotics. The patient has received i.v. administration of antibiotics within two weeks prior to first study treatment or oral antibiotics within one week prior to first study treatment.
- For female patients: the patient is pregnant or lactating.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01513109
Start Date
December 1 2011
End Date
December 1 2014
Last Update
January 20 2012
Active Locations (1)
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1
Institut Jules Bordet, tumor center of the Universite Libre de Bruxelles
Brussels, Belgium, 1000