Registry of Patients Having Received oNKord®
A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®
1 other identifier
observational
50
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
August 4, 2022
June 1, 2022
5.7 years
March 2, 2022
August 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of SAEs related to oNKord® 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
Study Arms (1)
Participants having received oNKord® as part of the WiNK clinical trial
WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® 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
Interventions
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
Lymphodepleting conditioning regimen
Eligibility Criteria
Participants who have received at least one dose of oNKord® 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.
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medizinische Hochschule Hannover
Hanover, Germany
University Hospital Basel
Basel, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 22, 2022
Study Start
June 14, 2022
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
August 4, 2022
Record last verified: 2022-06