EUCTR2017-002314-31-DE进行中（未招募）1 期
Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined with Blinatumomab in Patients with Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia after Allogeneic Stem Cell Transplantation - DLI-TARGET
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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)Patients with CD19+ B–precursor ALL (as determined by immunophenotyping) in hCR (defined as having less than 5% blasts in bone marrow) after allogeneic SCT.
- •2)One, or a combination of the following documented after an interval of at least 2 weeks since cessation of the most recent leukemia-targeting therapy (i.e. chemotherapy, immunotherapy or cellular therapy, except for intrathecal prophylaxis):
- •-Positivity for CD19+ MRD (molecular failure or molecular relapse), defined as presence of MRD at a level of =10-4 according to an assay with a minimum sensitivity of 10-4.
- •-Donor chimerism <90%, as determined by analysis of host and donor STRs in bone marrow sample engraftment analysis.
- •3)At least one previous line of treatment for MRD-positivity and/or reduced donor chimerism (i.e. blinatumomab, DLI, TKI or other agents) after allogeneic SCT.
- •4)For those with BCR/ABL-positive B-precursor ALL only: persistence of MRD and/or MC following at least one = second generation TKI (dasatinib, nilotinib, bosutinib, ponatinib) OR intolerance to second generation TKI and intolerance to or persistence of MRD and/or MC following imatinib mesylate.
- •5)Availability of allogeneic donor lymphocytes from the subject’s donor (at least 2 x 108 T cells/kg).
- •6)Subject (or subject's legally acceptable representative when the subject is legally too young to provide informed consent) has provided written informed consent prior to initiation of any study-specific activities/procedures.
- •7)Subject (or Subject’s legally acceptable representative when the subject is legally too young to provide informed consent) has provided informed consent to be followed up in the GMALL-Registry.
- •8)Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2.
- •9)Renal function as follows: serum creatinine < 2.0 mg/dL and estimated glomerular filtration rate > 30 mL/min.
- •10)Hepatic function as follows:
- •-Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 3.0 x upper limit of normal (ULN)
- •-Alkaline phosphatase (ALP) < 3.0 x ULN
- •-Bilirubin = 2.0 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1)Eligibility for treatment with blinatumomab ALONE or other antibody-based treatment approaches (e.g. inotuzumab ozogamicin), as considered by the treating physician.
- •2)Eligibility for standard chemotherapy, as considered by the treating physician.
- •3)Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives (whichever is longer) prior to baseline MRD and/or chimerism assessment.
- •4)Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment.
- •5)Any grade of GvHD currently requiring treatment.
- •6)Clinically relevant central nervous system (CNS) pathology requiring treatment (e.g., unstable epilepsy).
- •7)Evidence of current CNS involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully controlled prior to enrollment.
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