AML
Conditions
Keywords
NK cells, Umbilical cord blood, oNKord, Registry, Off the shelf
Brief summary
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
DRUGoNKord®
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
DRUGCyclophosphamide/Fludarabine (Cy/Flu)
Lymphodepleting conditioning regimen
Sponsors
Glycostem Therapeutics BV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SAEs related to oNKord® over time | 3 years | Safety |
| Incidence of SAEs related to Cyclophosphamide-Fludarabine over time | 3 years | Safety |
| Long-term follow-up on survival | 3 years | — |
| Long-term follow-up on disease status | 3 years | — |
| Long-term follow-up on cancer-related treatments | 3 years | — |
Countries
Germany, Switzerland
Contacts
Primary ContactKatarzyna Nowek, PhD
Outcome results
None listed