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Myelodysplastic SyndromesPhase 1/2NCT02752243

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

A Phase 1/2 study testing CIK-Cells in people with Myelodysplastic Syndromes and Acute Leukemia, run by Peter Bader at 5 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multi-site, non-randomized Phase I/II study involving children and adults. Read more about this study

Who is it for?
Ages 0 to 80 years
Conditions the study is for
Myelodysplastic Syndromes, Acute Leukemia
What is being tested?
CIK-Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
5 sitesGermany
Study dates
Mar 2016to Mar 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • University Medicine Duesseldorf, Department of Paediatric Oncology, Haematology and Immunology, Bone Marrow Transplantation Unit

    Düsseldorf, North Rhine-Westphalia, 40225

  • Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Internal Medicine II, Department of Hematology, Oncology, Rheumatology and Infectious Diseases, Goethe-University Frankfurt/Main

    Frankfurt am Main, Hesse, 60590

  • University Hospital Heidelberg, Ruprecht Karls University, Hospital for children and adolescents, Pediatrics III, Department of Oncology, Haematology, Immunology and Pneumology

    Heidelberg, Baden-Wurttemberg, 69120

  • Internal Medicine III, Department of Hematology and Oncology, Johannes Gutenberg University

    Mainz, Rhineland-Palatinate, 55101

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
CIK-Cells
Keywords
acute leukemia, myelodysplastic syndrome (MDS), Stem Cell Transplantation
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIK-CellsDrug

    IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.

Study groups in NCT02752243
Study groupRoleWhat they receive
CIK-CellsExperimentalIL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.
Receives: Drug: CIK-Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of grade three or four acute Graft versus Host Disease (aGvHD)

    Measured: two until four weeks after CIK-Cell Infusion

  2. Extensive chronic Graft versus Host Disease (cGvHD)

    Measured: two until four weeks after CIK-Cell Infusion

Secondary outcomes (2)

  1. Efficacy of CIK-Cells analyzed by progression free survival

    Measured: one year

  2. Overall survival

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752243
Sponsor's protocol ID
FFM-CIK-Cell Study 01
Other IDs
2013-005446-11
Status last verified
Mar 2022
First submitted
31 Mar 2016
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CIK-Cells in people with Myelodysplastic Syndromes and Acute Leukemia, run by Peter Bader at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of grade three or four acute Graft versus Host Disease (aGvHD) (time frame: two until four weeks after CIK-Cell Infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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