EUCTR2015-005399-12-DE进行中（未招募）1 期
A randomized controlled trial comparing outcome after hematopoietic cell transplantation from a partially matched unrelated versus haploidentical donor - HAMLET
DKMS gemeinnützige GmbH0 个研究点目标入组 266 人开始时间: 2016年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Signed written informed consent.
- •2) Males and females aged =18 years old.
- •3) Eligible diagnoses are listed below:
- •AML with adverse risk genetic abnormalities (according to the ELN guidelines)1.
- •AML with intermediate genetic abnormalities (according to ELN guidelines) either in first complete remission, after relapse, or with chemotherapy-refractory disease.
- •AML with favourable genetic abnormalities (according to ELN guidelines) after relapse or with chemotherapy-refractory disease, except APL.
- •AML with undefined genetic risk classification after relapse or with chemotherapy-refractory disease.
- •AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN guidelines) are present.
- •Therapy-related myeloid neoplasia except if favorable genetic abnormalities (according to ELN guidelines) are present.
- •MDS with high risk or very high risk disease (according to the IPSS-R score2).
- •First CR of high-risk ALL, defined by one or more of these:
- •- Early or mature T-ALL (CD1a negative).
- •- Pro B-ALL with t(4v;11); KMT2A-rearrangements
- •- Presence of BCR-ABL and/or t(9;22).
- •- Persistence of minimal residual disease after the second induction course.
- •ALL with or without complete remission after salvage therapy following poor response to induction therapy
- •ALL after haematological or molecular relapse.
- •4) Fit for transplant according to physician judgement.
- •5) No history of cardiac disease and absence of active symptoms, otherwise, documented left ventricular ejection fraction =40%.
- •6) No history of chronic pulmonary disease and absence of dyspnea. Otherwise, documented diffusion lung capacity for carbon monoxide (DLCO) =40% or FEV1/FVC = 50% despite appropriate treatment
- •7) Availability of =1 unrelated donor with a single allele or antigen mismatch at HLA-A, -B, -C, or -DRB1 and no concurrent DQB1 mismatch (9/10) shown by confirmatory typing.
- •8) Availability of at least one haploidentical donor meeting the following criteria:
- •Donor is a biologic parent / child of the patient or haploidentity has been confirmed for patient’s relatives by HLA-Typing.
- •The donor has expressed his / her will to donate, and has no contraindications against a stem cell donation by medical history.
- •Donor age is =18 years and =75 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 266
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 266
排除标准
- •1)Relapse or graft failure after a first allogeneic transplantation.
- •2)Thymic ALL in first complete remission.
- •3)Severe organ dysfunction defined by either of the following three criteria:
- •Patients who receive supplementary continuous oxygen.
- •Serum bilirubin >1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT >5 x ULN.
- •Estimated Glomerular Filtration Rate (GFR) < 40 ml/min, where:
- •Estimated GFR (mL/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
- •4)Uncontrolled infection at the time of enrollment.
- •5)Pregnant or breast-feeding women.
- •6)An HLA-identical sibling donor or 8/8 (HLA-A, -B, -C, or -DRB1) matched unrelated donor is available and suitable to donate prior to
- •randomization.
- •7)Men unable or unwilling to use adequate contraception methods from enrollment to minimum of six months after the last dose of
- •chemotherapy.
- •8)Women of childbearing potential except those who fulfill the following criteria: Post-menopausal or post-operative or continuous and
- •correct application of a contraception method with a Pearl Index <1% or sexual abstinence or vasectomy of the sexual partner.
- •9)Simultaneous participation in another clinical trial.
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