Deutsches Leukämie-Studienregister
Studie: HATCY

Kurzübersicht
Öffentlicher Titel Phase III Studie zu ATIR101 in der Stammzelltransplantation
Wissenschaftl. Titel Phase III Studie zu ATIR101 in der Stammzelltransplantation
Kurztitel HATCY
Studiennummer KN/ELN LN_NN_2019_655
Studiengruppe NN
Studienart multizentrisch, prospektiv, offen, zweiarmig
Studienphase Phase III
Erkrankung Stammzelltransplantation (SZT) - Diverse Erkrankungen
Leukämiestadium .
Kategorien Therapiestudie
Einschlusskriterien
  • Any of the following hematologic malignancies:
  • 1. Acute myeloid leukemia (AML) in first cytomorphological remission (with < 5% blasts in the bone marrow) with Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission (with < 5% blasts in the bone marrow)
  • 2. Acute lymphoblastic leukemia (ALL) in first or higher remission (with < 5% blasts in the bone marrow)
  • 3. Myelodysplastic syndrome (MDS): transfusion-dependent (requiring at least one transfusion per month), or intermediate or higher IPSS-R risk group)
  • Clinical justification of allogeneic stem cell transplantation where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner
  • Availability of a related haploidentical donor with one fully shared haplotype and 2 to 4 mismatches at the HLA-A, -B, -C, and -DRB1 loci of the unshared haplotype, as determined by high resolution HLA-typing
  • Karnofsky Performance Status (KPS) >= 70%
  • Male or female, age >= 18 years and <= 70 years Patients aged >= 65 years must have a Sorror score <= 3
  • Patient weight >= 25 kg and <= 130 kg
  • Availability of a donor aged >= 16 years and <= 75 years who is eligible according to local requirements and regulations. Donors aged < 16 years are allowed if they are the only option for an HSCT, if they are permitted by local regulations, and if the IRB/IEC approves participation in the study
  • For females of childbearing potential27 who are sexually active and males who have sexual contact with a female of childbearing potential: willingness to use reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) during study participation
  • Given written informed consent (patient and donor)
Ausschlusskriterien
  • Diagnosis of chronic myelomonocytic leukemia (CMML)
  • Availability of a suitable HLA-matched sibling or unrelated donor in a donor search
  • Prior allogeneic hematopoietic stem cell transplantation
  • Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) < 50% predicted
  • Left ventricular ejection fraction < 45% (evaluated by echocardiogram or MUGA scan)
  • AST and/or ALT > 2.5 x ULN (CTCAE grade 2)
  • Creatinine clearance < 50 ml/min (calculated or measured)
  • Positive pregnancy test or breastfeeding of patient or donor (women of childbearing age only)
  • Estimated probability of surviving less than 3 months
  • Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)
  • Known hypersensitivity to cyclophosphamide or any of its metabolites
  • Any contraindication for GVHD prophylaxis with mycophenolate mofetil, cyclosporine A, or tacrolimus
  • Known presence of HLA antibodies against the non-shared donor haplotype
  • Positive viral test of the patient or donor for HIV-1, HIV-2, HBV28, HCV28, Treponema pallidum, HTLV-1 (if tested), HTLV-2 (if tested), WNV (if tested), or Zika virus (if tested)
  • Any other condition that, in the opinion of the investigator, makes the patient or donor ineligible for the study
Alter 18 - 70 Jahre
Status Aktiv
Beginn der Rekrutierung 02.09.2019
Studienzentrale Universitätsklinikum Frankfurt
Kurzprotokoll Kurzprotokoll
Sponsoren Kiadis Pharma
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT02999854
European Clinical Trials Database - EUDRACT 2016-004672-21
erstellt 03.12.2019 Student Studienregister
geändert 03.12.2019 Student Studienregister
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