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ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKordĀ® (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 oNKordĀ® can be enrolled in this Registry.
To be eligible for this Registry, participants must have received at least one dose of oNKordĀ® 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 oNKordĀ® infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants having received oNKordĀ® as part of the WiNK clinical trial | WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKordĀ® in adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and not currently proceeding to hematopoietic stem cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oNKordĀ® | Drug | Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SAEs related to oNKordĀ® over time | Safety | 3 years |
| Incidence of SAEs related to Cyclophosphamide-Fludarabine over time | Safety | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have received at least one dose of oNKordĀ® in a clinical trial and are within 3 years of follow-up after the first infusion, and who have provided informed consent for participation in this Registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Nowek, PhD | Contact | +31(0)412211001 | medical@glycostem.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Recruiting | Hanover | Germany |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide/Fludarabine (Cy/Flu) | Drug | Lymphodepleting conditioning regimen |
|
| University Hospital Basel | Recruiting | Basel | Switzerland |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |