Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: CIK-Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After SCT.

Summary: Multi-site, non-randomized Phase I/II study involving children and adults.

Detailed description: This is a phase I/II multicenter-study to investigate the feasibility safety and efficacy of interleukin (IL)-15 activated CIK cells in patients with acute leukemia or myelodysplastic syndrome (MDS) showing evidence of relapse after allogeneic stem cell transplantation (SCT).
  CIK cell infusions will be given with an interval of 4-6 weeks according to a dose escalation schedule in patients with impending relapse after allogeneic SCT. In presence of acute graft versus host disease (aGvHD) ≥ grade II, the next scheduled infusion will not be administered.

Eligibility: Inclusion Criteria:
  -  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 treatment 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.
  Exclusion Criteria:
  -  • 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.

Relevance to patient case: definitely relevant