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

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ClinicalTrials.gov Identifier: NCT02752243
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Bader, Johann Wolfgang Goethe University Hospital

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Acute Leukemia Drug: CIK-Cells Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIK-Cells
IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.
Drug: CIK-Cells
IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.




Primary Outcome Measures :
  1. The occurrence of grade three or four acute Graft versus Host Disease (aGvHD) [ Time Frame: two until four weeks after CIK-Cell Infusion ]
  2. Extensive chronic Graft versus Host Disease (cGvHD) [ Time Frame: two until four weeks after CIK-Cell Infusion ]

Secondary Outcome Measures :
  1. Efficacy of CIK-Cells analyzed by progression free survival [ Time Frame: one year ]
  2. Overall survival [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Acute leukemia and MDS patients with molecular or cytogenetic relapse in peripheral blood (PB) or bone marrow (BM) samples obtained during monitoring for relapse after allogeneic SCT.

MRD detected by Ig/TCR gene rearrangement testing or any detected disease specific DNA or RNA sequence or disease specific cell surface Proteins or mixed recipient chimerism (MC) ≥ 1% and < 40%, or levels ≥ 10-4 of BCR-ABL/ABL ratio or any other disease specific cytogenetic abnormality will trigger CIK cell interventions.

  • Respecting MC, MC = 1% of autologous/recipient signals in PB samples must be confirmed by another PB or BM sample within one week. Patients with MC = 1% of autologous/recipient signals in CD33+ and/or CD34+ subpopulations in PB samples must be confirmed by BM analyses within one week. Acute leukemia and MDS patients with MC = 1% of autologous/recipient signals including signals in CD33+ and/or CD34+ subpopulations in BM samples must not be confirmed.
  • Acute leukemia and MDS patients with frank relapse ≥ 120 days after allogeneic SCT who achieved complete remission (CR) or blast clearance (i.e. <5% blasts) in the bone marrow after re-induction chemotherapy.
  • All patients must be in complete remission or have achieved blast clearance (i.e. <5% blasts) in the bone marrow before 1st CIK cell treatment (bone marrow assessment at a maximum of 7 days in advance of 1st treatment is obligatory).
  • Patients without immunosuppressive agents and steroids for at least 7 days.
  • Patients without chemo- or immune therapy during CIK cell treatment, except patients with thyrosine-kinase inhibitors (TKI) for treatment of BCR-ABL positive leukemia. Last DLI treatment must be 4 weeks before 1st CIK cell treatment.
  • Patients with < grade II aGvHD.
  • 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 5% and more malignant cells in a representative bone marrow analysis performed at a maximum of 7 days before 1st CIK cell treatment (obligatory).
  • 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 rapid T cell regeneration and any signs of 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 positive 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752243


Contacts
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Contact: Peter Bader, Prof. Dr. med. +49 69 6301 7542 peter.bader@kgu.de
Contact: Eva Rettinger, PD Dr. med. +49 69 6301 6063 eva.rettinger@kgu.de

Locations
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Germany
University Hospital Heidelberg, Ruprecht Karls University, Hospital for children and adolescents, Pediatrics III, Department of Oncology, Haematology, Immunology and Pneumology Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Johann Greil, Prof. Dr. med.    +49-6221-39518    johann.greil@med.uni-heidelberg.de   
Contact: Joachim Kunz, Dr.med.    +49-6221-5639836    joachim.kunz@med.uni-heidelberg.de   
Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt Recruiting
Frankfurt / Main, Hessen, Germany, 60590
Contact: Peter Bader, Prof. Dr. med.    +49 69 6301 7542    peter.bader@kgu.de   
Contact: Eva Rettinger, PD Dr. med.    +49 69 6301 6063    eva.rettinger@kgu.de   
Internal Medicine II, Department of Hematology, Oncology, Rheumatology and Infectious Diseases, Goethe-University Frankfurt/Main Recruiting
Frankfurt / Main, Hessen, Germany, 60590
Contact: Gesine Bug, PD Dr. med.    +49 69/6301-5398    g.bug@em.uni-frankfurt.de   
Contact: Salem Ajib, Dr. med.    +49 69/ 6301-5194    salem.ajib@kgu.de   
University Medicine Duesseldorf, Department of Paediatric Oncology, Haematology and Immunology, Bone Marrow Transplantation Unit Recruiting
Duesseldorf, North Rhine-Westphalia, Germany, 40225
Contact: Roland Meisel, Prof. Dr. med.    +49 (0) 211 - 81-18907    meisel@med.uni-duesseldorf.de   
Contact: Friedhelm Schuster, Dr. med.    +49 (0) 211 - 81-19160    friedhelm.schuster@med.uni-duesseldorf.de   
Internal Medicine III, Department of Hematology and Oncology, Johannes Gutenberg University Recruiting
Mainz, Rhineland Palatinate, Germany, 55101
Contact: Eva Wagner, Dr. med.    +49 6131 17-3967    eva.wagner@unimedizin-mainz.de   
Contact: Beate Hauptrock, Dr. med.    +49 6131 17-3967    beate.hauptrock@unimedizin-mainz.de   
Sponsors and Collaborators
Peter Bader

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Responsible Party: Peter Bader, Prof. Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02752243     History of Changes
Other Study ID Numbers: FFM-CIK-Cell Study 01
2013-005446-11 ( EudraCT Number )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peter Bader, Johann Wolfgang Goethe University Hospital:
acute leukemia
myelodysplastic syndrome (MDS)
Stem Cell Transplantation

Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Syndrome
Leukemia
Myelodysplastic Syndromes
Preleukemia
Acute Disease
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes