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

Goethe-University Frankfurt0 sites40 target enrollmentSeptember 25, 2014

Conditionsrelapsing acute leukemia, relapsing myelodysplastic syndromes MedDRA version: 17.0Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864 MedDRA version: 17.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851 Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsZytokin-aktivierte Killerzellen (CIK-Zellen), allogen

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: relapsing acute leukemia, relapsing myelodysplastic syndromes
Sponsor: Goethe-University Frankfurt
Enrollment: 40
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 25, 2014

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Goethe-University Frankfurt

Eligibility 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 \< 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20

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.