relapsing acute leukemia, relapsing myelodysplastic syndromes MedDRA version: 17.0 Level: LLT Classification code 10000835 Term: Acute leukemia System Organ Class: 100000004864 MedDRA version: 17.0 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Zytokin-aktivierte Killerzellen (CIK-Zellen), allogen
Product Name: CIK-Cells
Pharmaceutical Form: Infusion
Sponsors
Goethe-University Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Acute leukemia and MDS patients with cytogenetic relapse or detectable MRD in peripheral blood (PB) or bone marrow (BM) samples obtained during monitoring for relapse after allogeneic SCT. Increasing MRD levels or levels = 10-4 of BCR-ABL/ABL ratio or Ig/TCR gene rearrangements will trigger CIK cell intervention in ALL patients. • Acute leukemia and MDS patients with 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 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 CD34+ subpopulations in BM samples. • Acute leukemia and MDS patients with hematologic relapse = day 120 after allogeneic stem cell transplantation eligible for chemotherapy with less than 5% malignant cells in bone marrow analyses performed after cytoreductive chemotherapy. Re-induction chemotherapy regime will be offered per investigator`s choice. • Patients without immunosuppressive agents and steroids. • Patients without additional than pre-existing chemo- or immune modulatory therapy • Patients with =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Acute leukemia and MDS patients with hematologic relapse before day 120 or patients not eligible or without significant response to re-induction chemotherapy. • Patients with immunosuppressive agents or steroids. • Patients with additional than pre-existing chemo- or immune modulatory therapy • 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Molecular, cytogenetic or hematological response as efficacy end point - Progression free survival at 1 year after initiation of CIK cell therapy - Overall survival will be assessed 1 year after initiation of CIK cell therapy. ;Timepoint(s) of evaluation of this end point: after 1 year | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and feasibility of increasing cell doses of CIK cell transfusions in adult and pediatric leukemia and MDS patients with molecular, cytogenetic or hematologic relapse after allogeneic SCT. ;Secondary Objective: To assess the efficacy of CIK cell treatment based on: • Reduction or disappearance of MRD, • Achievement of complete donor chimerism, • Rate of and time to hematologic relapse in patients enrolled based on MRD and/or mixed chimerism, and • Rate and duration of complete hematologic response following CIK cell administration in patients enrolled with overt relapse • Progression-free and overall survival ;Primary end point(s): - The dose-limiting toxicity based on grade III or IV acute GvHD - Chronic limited and extensive GvHD ;Timepoint(s) of evaluation of this end point: variable | — |
Countries
Germany
Contacts
Public ContactDivision Stem Cell Transplantation
Department for Children and Adolescents, University Hospital Frankfurt
Outcome results
None listed