Acute myeloid leukaemia Myelodysplastic syndrome, unspecified
Conditions
Interventions
Doses will be available in 3 different concentrations:
Level 1 1x107/kg
Level 2 5x107/kg
Level 3 1x108/kg
Three patients will be submitted to first concentration. If no toxicities are observed we will
Drug
Biological/vaccine
Q35.060
A11.118.637.555.567.537
Sponsors
Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein
Eligibility
Age
3 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with relapsed acute myelogenous leukemia, including CNS diseases or previous hematopoietic stem cell transplantation, who have failed remission for at least one cycle of standard or experimental re-induction chemotherapy or primary refractory AML (primary AML failed to achieve remission after at least two cycles of induction therapy); Patient with high risk AML or MDS without donor for allogeneic transplantation available at the time of therapy; Patients with performance status ? 2 on Zubrod scale (ECOG) or Lansky 60; Organic function with respiratory capacity 50%, pulmonary symptoms controlled by medication and pulse oximetry greater than or equal to 92%; Creatinine ?2 mg / dL for adults, ?2 mg / dL or ?2 the upper limit of normal for age for children, or with creatinine clearance ?60 mL / min / 1.73 m2; Total bilirubin ? 2 mg / dL or TGP (ALT) III; Negative pregnancy test for women of childbearing age (non-fertile age defined as pre-menarche, post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women of childbearing age; Patient should have recovered from the toxicity related to previous treatment of cytotoxic agents received within 4 weeks before starting treatment in this protocol (with the exception of cytopenias resulting from persistent disease and alopecia)
Exclusion criteria
Exclusion criteria: Patients with high-risk AML and MDS with active, HIV-positive hepatitis B or C; With liver cirrhosis; Uncontrolled infections; Female patients with positive pregnancy test; Congestive heart failure <6 months before screening; Unstable breast angina <6 months before selection; Myocardial infarction <6 months before selection; Non-signing free and informed consent term
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome in this study is the safety and eficacy of the treatment in AML and MDS patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival in 12 months. ;2. Parameters such as recovery of NK cells in infused patients, analysis of chimerism and immunophenotyping will be evaluated. ;3. Patients will be monitored for the occurrence of acute or chronic GVHD. All patients will be followed in this protocol (considered "under study") until day +56, until they have progression of the disease or until they reach remission and begin another consolidation therapy (whichever occurs earlier.;4. Patients will be observed intensively before and during infusion. Allergic NK cell infusions will be stopped in the event of severe allergic reactions involving the common terminology criteria for NCI adverse events (CTCAE). ;5. Cardiopulmonary, hepatic (excluding albumin) neurological or renal events that occur are probably or definitely attributed to the infusion of NK cell products. | — |
Countries
Brazil
Contacts
Public ContactNelson Hamerschlak
Hospital Israelita Albert Einstein
Outcome results
None listed