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 - GC P#05.01.020

Gamida Cell ltd.0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Gamida Cell ltd.
入组人数: 15

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

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 12 至 99（—）

入选标准

•1. 12-65 years of age;2. Patients with one of the following hematological malignancies:
•- Acute lymphoblastic leukemia (ALL) at one of the following stages:
•a. High risk first complete morphologic remission (CR1),
•b. Second or subsequent remission
•- Acute myelogenous leukemia (AML) at one of the following stages:
•a. First complete morphologic remission (CR1) that is NOT considered as favorable-risk.
•b. Patients in CR1 with one or more of the favourable risk criteria but with additional high risk features may be considered eligible upon consultation with the study chairs.
•c. Second or subsequent remission
•- Chronic myelogenous leukemia (CML) at one of the following phases:
•a. Chronic phase
•b. Accelerated phase
•c. Prior blast crisis (myeloid or lymphoid) currently in chronic phase or in complete morphologic or molecular remission
•-CMMol or MDS/CMMol overlap with spleen size <13cm
•-Myelodysplastic Syndrome (MDS) with history of one or more of the following:
•International Prognostic Scoring System (IPSS) risk category of INT-1 or greater. MDS patients categorized as INT-1 on primary presentation must have life threatening neutropenia or thrombocytopenia.
•Revised International Prognostic Scoring System (IPPS-R) risk category of intermediate or greater
•- Biphenotypic/undifferentiated/Prolymphocytic/DC Leukemias and NK Cell Malignancies in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR
•- Lymphoma, meeting one or more of the following criteria:
•Burkitt's lymphoma in second or subsequent CR
•Or High risk lymphomas in first CR, including enteropathy-associated T cell lymphoma and hepatosplenic gammadeltaT cell lymphoma
•Or Chemotherapy-sensitive (at least stable disease) lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are not candidates for an autologous transplant. (Patients with CLL are not eligible regardless of disease status);3. CBU criteria as described above.;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 backup to the NiCord arm in case of production failure. The backup 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 backup CBU is recommended to be added in the below cases:
•- if the backup CBU is HLA-matched at 5-or 6/6, and contains a pre-cryopreserved (post processing) total nucleated cell dose of <2.5x107 TNC/kg, OR a pre-cryopreserved (post processing) CD34+ cell dose of <1.2 x105 CD34+ cells/kg.
•- if the backup CBU is HLA-matched at 4/6, and contains a pre-cryopreserved (post processing) total nucleated cell dose of <3.5x107 TNC/kg, OR a pre-cryopreserved (post processing) CD34+ cell dose of <1.7 x105 CD34+ cells/kg.
•In case of two backup CBUs, the second backup CBUs 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 backup CBUs are recommended to have a combined pre-cryopreserved (post processing) total nucleated cell dose of at least 3x107 TNC/kg.;5. Patient*s Performance score >=70% by Karnofsky or Lansky;6. Patient has sufficient physiologic reserves including:
•a. Cardiac: Left ventricular ejection fraction (LVEF) of >=40% by echocar

排除标准

•1. MDS or CML with *marked* or *3+* fibrosis;2. CLL;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 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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