Status:
UNKNOWN
Safety and Feasibility of the Use of Natural Killer Cells in Patients With Chronic Myeloid Leukemia
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
2-59 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate safety, feasibility and maximum tolerated dose of NK cells cultured in vitro as adjuvant treatment of patients with chronic myeloid leukemia candidates to allo...
Detailed Description
Natural killer (NK) cells are one of the main type of immune cells that mediate the graft-versus-leukemia (GVL) effect. They are a fundamental part of innate immunity, with a major role in rapid respo...
Eligibility Criteria
Inclusion
- Patients with chronic phase CML who lost response to the second line of treatment with tyrosine-kinase inhibitor (TKI) with indication for bone marrow transplantation.
- Accelerated phase patients who are candidates for bone marrow transplantation.
- Patient with CML in blast crisis.
- Patient aged between 2 and 59 years.
- patient should have recovered from the toxicity related to previous treatment of cytotoxic agents received within 4 weeks before starting treatment in this protocol, except for cytopenias resulting from persistent disease and alopecia, or non-haematological toxicities grades 1 and 2
Exclusion
- Zubrod performance scale ≥ 2
- Renal impairment: Serum creatinine\> 2mg / dL for adults and\> 2mg / dL or\> 2 times the upper limit of normality for age (whichever is less) for children.
- Impaired hepatic function, defined as: total bilirubin\> 2 mg / dL and alanine aminotransferase (ALT) 2.5 times upper limit of normal for age (unless Gilbert's disease or abnormal liver function due to primary disease).
- Pulmonary symptoms with pulse oximetry \<92%.
- Congestive Heart Failure Classification New York Heart Association\> III
- Positive serological test for pregnancy within two weeks prior to enrollment in women of childbearing potential (non-fertile age defined as pre-menarche, post-menopausal over one year, or surgically sterilized).
- Positive serology for human immunodeficiency virus (HIV).
- Have undergone investigational therapies in four weeks prior to treatment begin under this protocol.
- Congestive heart failure \< 6 months prior to screening.
- Unstable angina \< 6 months before screening.
- Myocardial infarction \< 6 months prior to selection.
- Non-signing of the informed consent.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03348033
Start Date
March 1 2019
End Date
March 1 2023
Last Update
March 12 2019
Active Locations (1)
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1
Centro Terapia e Tecnologia Celular
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903