AMLNCT05290662
Registry of Patients Having Received oNKord®
An observational study of AML, run by Glycostem Therapeutics BV at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- oNKord® and Cyclophosphamide/Fludarabine (Cy/Flu)
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jun 2022to Mar 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover
Prof. Dr. Michael Heuser, MD
About this study
Official title: A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®
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.
Read the 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.
- Conditions
- AML
- Being tested
- oNKord®, Cyclophosphamide/Fludarabine (Cy/Flu)
- Keywords
- NK cells, Umbilical cord blood, oNKord, Registry, Off the shelf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oNKord®Drug
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
Cyclophosphamide/Fludarabine (Cy/Flu)Drug
Lymphodepleting conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: oNKord®; Drug: Cyclophosphamide/Fludarabine (Cy/Flu) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SAEs related to oNKord® over time
Safety
Measured: 3 years
Incidence of SAEs related to Cyclophosphamide-Fludarabine over time
Safety
Measured: 3 years
Long-term follow-up on survival
Measured: 3 years
Long-term follow-up on disease status
Measured: 3 years
Long-term follow-up on cancer-related treatments
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start14 Jun 2022
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Glycostem Therapeutics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290662
- Sponsor's protocol ID
- ReKORD
- Status last verified
- Jun 2022
- First submitted
- 2 Mar 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No