NCT07566377招募中2 期
Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to find out whether Cord Blood Transplantation/CBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
- •° Disease type
- •Cohort 1, High Risk Disease: Patients with age ≤ 26 years at the time of informed consent with no available and suitably matched related or unrelated donor within 4 weeks, with one of the following diagnoses:
- •I. Acute myelogenous leukemia (AML):
- •Complete first remission (CR1) with blast count < 5% by bone marrow morphology at high risk for relapse such as any of the following:
- •Known prior diagnosis of myelodysplasia (MDS)
- •High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and/or high-risk molecular abnormalities (e.g., TP53)
- •Requirement for 2 or more inductions to achieve CR1
- •Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and/or gene therapy or cell therapy)
- •Presence of Minimal/Measurable Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods (at End of Induction or End of Consolidation)
- •Other high-risk features not defined above.
- •Complete second remission (CR2) or subsequent remission, with blast count < 5% by bone marrow morphology
- •Presence of MRD by multiparameter flow cytometry at pre-transplant evaluation is acceptable.
- •II. Acute lymphoblastic leukemia (ALL):
- •Complete first remission (CR1) with MRD negative status by multicolor flow cytometry, at high risk for relapse such as any of the following:
- •Presence of any high risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other, KMT2A (11q23) or other high risk molecular abnormality
- •Failure to achieve complete remission (CR) after four weeks of induction therapy (transplant to follow antibody therapy and/or CAR T cells)
- •Persistence or recurrence of MRD on therapy (Transplant to follow antibody therapy and/or CAR T cells)
- •T-ALL in CR even with presence of MRD
- •Other high-risk features not defined above
- •Complete second remission (CR2) or subsequent remission with MRD negative status by multiparameter flow cytometry.
- •Relapse in less than 36 months from CR1
- •Relapse for T-ALL
- •Patients after antibody therapy (e.g., blinatumomab, inotuzumab, other) and/or CAR-T cell therapy that resulted in MRD negative status by multiparameter flow cytometry.
- •III. Other acute leukemias:
- •Leukemias of ambiguous lineage or of other types with < 5% blasts by bone marrow morphology.
- •Patients with persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in < 5% of cells.
- •Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase.
- •Any leukemia that developed after gene therapy or cell therapy
- •IV. Myelodysplastic Syndrome (MDS):
- •Any IPSS risk category with life-threatening cytopenia(s).
- •Any IPSS risk category with high risk cytogenetic/molecular findings (5, 7, 8, complex karyotype, or TP53)
- •V. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high risk of relapse or progression if not in remission:
- •Patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell NHL) in CR.
- •Patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease/ CR/ PR with no single lesion equal to or more than 5 cm.
- •Patients with HL without progression of disease (POD) after salvage chemotherapy with no single lesion ≥5 cm.
- •Cohort 2: Very High-Risk disease:
- •Patients in CR (bone marrow blasts <5% by morphology) who had prior allogeneic transplant and disease recurrence. The second transplant will take place at least 4 months after the first.
- •Acute myelogenous leukemia (AML) or Myelodysplastic Syndrome (MDS): Relapse after previous transplant, in CR after induction therapy. MRD positive status by multi-parameter flow cytometry is accepted.
- •Acute lymphoblastic leukemia (ALL): Relapse after previous transplant, in CR after induction therapy and/or antibody therapy/CAR T cells. MRD positive status after targeted therapy, as evaluated by multi-parameter flow cytometry is accepted.
- •Other: patients with leukemia or lymphoma, who, in the opinion of their physician, are not likely to have reduction in disease burden with further chemotherapy.
- •Patients with relapsed/refractory disease at either first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology. ° Relapse after previous transplant with < 30% blasts by bone marrow morphology, or with cytogenetic, flow cytometric, or molecular abnormalities in < 30% of bone marrow cells, after induction therapy.
- •° Primary refractory or relapsed AML with < 30% blasts by bone marrow morphology or with cytogenetic, flow cytometric, or molecular abnormalities in < 30% of bone marrow cells.
- •° Age 0-26 years at the time of informed consent
- •° Performance: Karnofsky (≥16 years) or Lansky score (<16 years) of ≥70% (see Appendix A).
- •° Not Pregnant and Not Nursing
- •° Required Organ Function
- •Bilirubin ≤ 1.5 mg/dL (unless benign congenital hyperbilirubinemia).
- •ALT ≤ 3 x upper limit of normal.
- •Pulmonary function (FVC, FEV1 and DLCO corrected for hemoglobin) ≥ 50% predicted.
- 另有 7 项未显示
排除标准
- •Exclusion criteria for both cohorts:
- •° Inadequate performance status/ organ function.
- •° Active CNS leukemic involvement.
- •Chloroma >2 cm.
- •Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.
- •HIV infection.
- •Seropositivity for HTLV-
- •Pregnancy or breast feeding.
- •Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.
- •Any abnormal condition or lab result that is considered by the PI capable or altering patient's condition or study outcome.
- •Cohort 2 Very High-Risk Disease (additional to above):
- •° Allogeneic HCT in the preceding 4 months.
- •Note (1): Prior checkpoint inhibitors/blockade in the last 12 months: eligibility to be discussed with study PI.
- •Note (2): For patients with known HBV and/or HCV infection :
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- •Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
研究者
研究点 (7)
Loading locations...
相似试验
Unknown
不适用
儿童优化 Haplo-Cord 模式造血干细胞移植多中心临床研究ChiCTR2000036368上海申康医院发展中心60
Unknown
不适用
儿童优化 Haplo-Cord 后置模式在造血干细胞移植的临床研究ChiCTR2000037486上海申康医院发展中心
Unknown
1 期
CAR-T 细胞治疗复发难治白血病的临床研究ChiCTR-OIH-17012645自筹经费22
Unknown
2 期
优化 Haplo-Cord 模式在儿童造血干细胞移植应用的临床研究ChiCTR2000029458上海市卫生健康委员会60
招募中
1/2 期
CNCT19 细胞注射液治疗儿童和青少年 CD19 阳性的复发或难治性急性 B 细胞型淋巴细胞白血病的多中心、开放、单臂、Ⅰb/Ⅱ期临床试验儿童和青少年 CD19 阳性的复发或难治性急性 B 细胞型淋巴细胞白血病CTR20223262合源生物科技（天津）有限公司