EUCTR2016-000704-28-FR进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •1.12-65 years of age
- •2.Patients with one of the following HM (or according to
- •local guidelines/recommendations if these are more stringent) : 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
- •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 (or according to local guidelines/recommendations if these are more stringent) 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
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