Deutsches Leukämie-Studienregister
Studie: CIK-Cell Study

Kurzübersicht
Öffentlicher Titel Phase I/II Studie zu IL-15 aktivierten Cytokininduzierten Killerzellen (CIK) bei akuten Leukämien und MDS nach allogener SZT
Wissenschaftl. Titel A prospective phase I/II study to investigate the feasibility, safety and efficacy of IL-15 activated cytokine induced killer (CIK) cells in relapsing patients with acute leukemia or myelodysplastic syndromes after allogeneic stem cell transplantation
Kurztitel CIK-Cell Study
Studiennummer KN/ELN LN_NN_2016_646
Studiengruppe NN
Studienart multizentrisch, einarmig, prospektiv, offen
Studienphase Phase I/II
Erkrankung Akute lymphatische Leukämie (ALL) - Alle Subtypen
Myelodysplastisches Syndrom (MDS) - Alle Subtypen
Leukämiestadium rezidiviert/refraktär
Einschlusskriterien
  • Acute leukemia and MDS patients with molecular relapse in peripheral blood (PB) or bone marrow (BM) samples obtained during monitoring for relapse after allogeneic SCT
  • 1. MRD detected by Ig/TCR gene rearrangements testing or
  • 2. confirmed mixed chimerism (MC) >= 1%, or
  • 3. levels >= 10-4 of BCR-ABL/ABL ratio will trigger CIK cell interventions
  • Respecting MC, MC >= 1% of autologous signals in PB samples confirmed by another PB or BM sample within one week. Patients with MC >= 1% of autologous signals in CD33+ and/or CD34+ subpopulations in PB samples confirmed by BM analyses within one week. Acute leukemia and MDS patients with MC >= 1% of autologous signals including signals in CD33+ and/or CD34+ subpopulations in BM samples
  • Patients without immunosuppressive agents and steroids
  • Patients without chemo- or immune therapy, except patients with thyrosine-kinase inhibitors (TKI) for reatment of BCR-ABL positive leukemias
  • Patients with < grade II GvHD
  • Patients with Karnowsky or Lansky performance status >= 50%.
  • Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have given written informed consent
Ausschlusskriterien
  • Acute leukemia and MDS patients with hematologic relapse < day 120 after allogeneic stem cell transplantation
  • Patients with more than 5% malignant cells in bone marrow analyses
  • Patients with immunosuppressive agents or steroids
  • Patients with chemo- or immune therapy, except patients with thyrosine-kinase inhibitors (TKI) for BCR-ABL positive leukemias
  • Patients with >= grade II GvHD
  • Patients with Karnowsky or Lansky performance status < 50%
  • Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have not given written informed consent
  • HIV-positive patients
  • HBV/HCV patients
  • Patients with prior solid organ transplantation
  • Patients treated with any other investigational product within the last 28 days or five half-lives (whichever is longer).
  • Hypersensitivity to any component of the study drug
  • Female patients of child-bearing potential not agreeing to use a highly effective method of birth control resulting in a low failure rate (i.e. < 1%) when used consistently and correctly
  • Male patients with female partners of childbearing potential not agreeing to use a highly effective method birth control resulting in a low failure rate (i.e. < 1%) when used consistently and correctly
  • Pregnancy/Breastfeeding
  • Patients with severe infections or signs/symptoms of infection within 2 weeks prior to study start
Alter <= 75 Jahre (0-80J)
Status Aktiv
Beginn der Rekrutierung 24.03.2016
Kurzprotokoll Kurzprotokoll
Sponsoren Goethe-Universität Frankfurt am Main
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT02752243
European Clinical Trials Database - EUDRACT 2013-005446-11
erstellt 29.04.2019 Student Studienregister
geändert 29.04.2019 Student Studienregister
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