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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT02752243
• Date of registration: 31/03/2016
• Prospective Registration: No
• Primary sponsor: Peter Bader
• Public title: CIK-Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After SCT.
• Scientific 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
• Date of first enrolment: March 2016
• Target sample size: 32
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02752243
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Leukemia

Myelodysplastic Syndromes

Intervention(s)

Drug: CIK-Cells

Primary Outcome(s)

The occurrence of grade three or four acute Graft versus Host Disease (aGvHD) [Time Frame: two until four weeks after CIK-Cell Infusion]

Extensive chronic Graft versus Host Disease (cGvHD) [Time Frame: two until four weeks after CIK-Cell Infusion]

Secondary Outcome(s)

Efficacy of CIK-Cells analyzed by progression free survival [Time Frame: one year]

Overall survival [Time Frame: one year]

Secondary ID(s)

2013-005446-11

FFM-CIK-Cell Study 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors