HAPLOIDENTICAL BONE MARROW TRANSPLANTATION FROM NK ALLOREACTIVE DONORS FOR PATIENTS WITH HIGH RISK ACUTE MYELOID LEUKEMIA - A PHASE 2 STUDY - NK alloreactive haploidentical bone marrow transplantation for leukemia

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•AML/RAEB patients < 76 years,
•very poor risk based on at least one of the following criteria (modification of criteria in HOVON 132 study):
•- no CR after first remission-induction course,
•- MRD+ by WT1 testing after induction chemotherapy and no [t(8;21) or AML1-ETO and WBC <20], no inv16/t(16;16) or CBFB-MYH11, no CEBPA-biallelic mutation, or no FLT3ITD-/NPM1+.
•- MRD+ by flowcytometry after 1st consolidative chemotherapy and no [t(8;21) or AML1-ETO and WBC <20], no inv16/t(16;16) or CBFB-MYH11, no CEBPA-biallelic mutation, or no FLT3ITD-/NPM1+.
•- Abn 3q26,
•- No CBF, EVI1+,
•- No CBF, abn(17p) or p53 mutation,
•- RUNX1 mutation or ASXL1 mutation
•- Bi-allelic FLT3-ITD with FLT3-ITD/FLT3wt ratio of >0.6
•- Relapsed AML
•susceptible for NK-cell alloreactivity
•the availability of a NK cell alloreactive haploidentical bone marrow donor
•Written informed consent

•- Active uncontrolled infections
•- Uncontrolled CNS involvement by the malignant disease
•- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
•- Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix ???);
•- Severe neurological or psychiatric disease;
•- Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times upper limit of normal)
•- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
•- History of active malignancy during the past year with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
•- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
•- Breast-feeding female patients.

发起方

Medisch Universitair Ziekenhuis Maastricht