Registry of Patients Having Received oNKord®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oNKord®, Cyclophosphamide/Fludarabine (Cy/Flu).
- Who it may be relevant to
- Registry conditions: AML. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®
Overview
ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKord® (allogeneic ex vivo-generated Natural Killer \[NK\] cells from CD34+ umbilical cord blood progenitor cells) in a clinical trial. Participants from multiple previous clinical trials of oNKord® can be enrolled in this Registry.
Detailed description
To be eligible for this Registry, participants must have received at least one dose of oNKord® in a clinical trial. Eligible participants will be enrolled after signing the informed consent form (ICF). Participant characteristics, treatment history, and clinical trial outcome data at clinical trial discontinuation/completion will be collected. On a yearly basis after the last clinical trial visit, the investigator will collect the participants' medical status and enter them in the Registry database. Major clinical events, including concomitant medication or therapy, that occurred since the previous assessment will be recorded. No protocol-specific visits or interventions will be required. Participants will be followed up until 3 years after the first oNKord® infusion.
Interventions
- Drug oNKord®
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells - Drug Cyclophosphamide/Fludarabine (Cy/Flu)
Lymphodepleting conditioning regimen
Primary outcome measures
- Incidence of SAEs related to oNKord® over time [Time frame: 3 years]
- Incidence of SAEs related to Cyclophosphamide-Fludarabine over time [Time frame: 3 years]
- Long-term follow-up on survival [Time frame: 3 years]
- Long-term follow-up on disease status [Time frame: 3 years]
- Long-term follow-up on cancer-related treatments [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Receipt of at least one dose of oNKord® in a clinical trial
- Participation must be within 3 years after the first infusion of oNKord®
- Signature of ICF
Exclusion criteria
- N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Medizinische Hochschule Hannover — Hanover
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT05290662 · ReKORD