A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

Gamida Cell Ltd0 个研究点目标入组 120 人开始时间: 2016年12月15日最近更新: 2021年4月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Gamida Cell Ltd
入组人数: 120

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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

•1.12-65 years of age
•2.Patients with one of the following HM: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), CMMoL or MDS/CMMoL overlap, Myelodysplastic Syndrome (MDS) and Lymphoma as defined in the protocol. Biphenotypic/undifferentiated/Prolymphocytic/Dendritic Cell
•Leukemias and Natural Killer Cell Malignancies in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR. Patients with CLL are not eligible regardless of disease status.
•3.CBU criteria as described in the protocol;
•4.Patients who will be starting conditioning prior to NiCord release for infusion (i.e., NiCord arrival on site in adequate condition) must have an additional partially HLA-matched CBU reserved as a BU to the NiCord arm in case of production failure. The BU CBU must be HLA-matched at 4-6/6 HLA class I(HLA-A&HLA-B, low resolution) and II (HLA-DRB1,high resolution) loci with the patient. A second BU CBU is recommended to be
•added in the below cases: If the BU CBU is HLA matched at 5-or 6/6, and contains a pre-cryopreserved total nucleated cell dose of<2.5x10^7 TNC/kg, OR a pre- cryopreserved CD34+ cell dose
•of<1.2 x10^5CD34+ cells/kg. If the BU CBU is HLA-matched at 4/6, and contains a pre-cryopreserved total nucleated cell dose of<3.5x10^7 TNC/kg, OR a pre cryopreserved CD34+ cell dose of
•<1.7x10^5CD34+cells/kg. In case of two BU CBUs, the second BU CBU must also be HLA-matched at 4-6/6 HLA class I(HLA-A&HLA-B, low resolution) and II (HLA-DRB1,high resolution) loci with the patient. The BU CBUs are recommended to have a combined pre-cryopreserved total nucleated cell dose of at least 3x10^7 TNC/kg.
•5.Patient's Performance score =70% by Karnofsky or Lansky
•6. Patient has sufficient physiologic reserves including: a.Cardiac: LVEF of =40% by echocardiogram, radionuclide scan or cardiac MRI or Left
•ventricular shortening fraction = 29%. b.PFT demonstrating FVC and FEV1 of >50% of predicted for age and cDLCO>50% of predicted for
•patients in whom pulmonary function testing can be performed c.Renal: Creatinine clearance test =60mL/min d.Hepatic: Serum Bilirubin<2.0 mg/dl; Hepatic transaminases<3xupper limit of normal range
•7.Females of childbearing potential, defined as any female who has experienced menarche and is not postmenopausal or permanently sterilized, agree to use an appropriate method of contraception from at least 7 days prior to conditioning regimen therapy until completion of FU procedures.
•8.Patient signs the written informed consent after being aware of the nature of the patient's disease and willingly consents to the treatment program after being informed of alternative treatments, potential risks, benefits, and discomforts
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1.MDS or CML with marked” or 3+” fibrosis
•3.Fewer than 21 days have elapsed since initiation of the patient's last chemotherapy cycle and the initiation of the stem cell transplant preparative regimen (radiotherapy,intrathecal agents, hydroxyurea, tyrosine kinase inhibitors, hypomethylating agents, rituximab, blinatumomab and lenalidomide are not considered chemotherapy)
•4.Persistent clinically significant toxicities that, in the investigator's opinion, make the patient unsuitable for transplant
•5.Evidence of donor specific anti-HLA antibodies to the selected treatment CBU #1 (MFI>3000 to HLA A, B, C, or DRB1)
•6.Evidence of HIV infection or HIV positive serology
•7.Evidence of active Hepatitis B or Hepatitis C as determined by serology or PCR
•8.Pregnancy, as indicated by a positive serum or urine human chorionic gonadotrophin (HCG) test, or lactation
•9.Active malignancy other than that for which the UCB transplant is being performed within 12 months of enrollment. Fully resected cutaneous squamous cell or basal cell carcinoma or cervical carcinoma in situ within 12 months of enrollment will be permitted.
•10.Evidence of uncontrolled bacterial, fungal or viral infections or severe concomitant diseases, which in the judgment of the Principal investigator indicate that the patient could not tolerate transplantation
•11.Patients with presence of leukemic blasts in the central nervous system (CNS)
•12.Patients with an 8/8 allele level HLA-matched and readily available related or unrelated donor (whose stem cells can be collected in a timely manner without jeopardizing recipient outcome). Patients who have haploidentical related donors or syngeneic donors will not be excluded
•13.Prior allogeneic hematopoietic stem cell transplant
•14.Allergy to bovine products, gentamicin, or to any other product that may interfere with the treatment
•15.Psychologically incapable of undergoing bone marrow transplant (BMT) with associated strict isolation or documented history of medical non-compliance and/or psychiatric illness and/or social situations that would limit compliance with study requirements
•16.Enrolled in another interventional clinical trial or received an investigational treatment within 30 days prior to the approved date of randomization, unless documented approval obtained from Sponsor prior to the anticipated date of randomization, unless documented approval obtained from Sponsor prior to randomization

研究者

发起方

Gamida Cell Ltd

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A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignanciescancer in white blood cells10024324leukemia

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