NCT02752243

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

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 SCT

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Peter Bader · Academic / Other
• Sex: All
• Age: 0 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes
• Acute Leukemia

Interventions

Type	Name	Description
DRUG	CIK-Cells	IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.

Timeline

• Start date: 2016-03-01
• Primary completion: 2023-03-01
• Completion: 2024-03-01
• First posted: 2016-04-26
• Last updated: 2022-04-01

Locations

5 sites across 1 country: Germany