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 transplantatio

Phase 1

• Conditions: relapsing 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]

• Registration Number: EUCTR2013-005446-11-DE
• Lead Sponsor: Goethe-University Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-25
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• Reduction or disappearance of MRD,<br>• Achievement of complete donor chimerism,<br>• Rate of and time to hematologic relapse in patients enrolled based on MRD and/or mixed chimerism, and <br>• Rate and duration of complete hematologic response following CIK cell administration in patients enrolled with overt relapse<br>• Progression-free and overall survival<br> <br><br>;Primary end point(s): - The dose-limiting toxicity based on grade III or IV acute GvHD <br>- Chronic limited and extensive GvHD<br><br>;Timepoint(s) of evaluation of this end point: variable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Molecular, cytogenetic or hematological response as efficacy end point<br>- Progression free survival at 1 year after initiation of CIK cell therapy<br>- Overall survival will be assessed 1 year after initiation of CIK cell therapy. <br><br>;Timepoint(s) of evaluation of this end point: after 1 year