MDS-EBPhase 1/2NCT04599426
Allogenic NK Cell Transfusion Azacitidine MDS-EB
A Phase 1/2 study testing Allogeneic NK cell regimen group in people with MDS-EB, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- MDS-EB
- What is being tested?
- Allogeneic NK cell regimen group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
- Patients with age 15 years to 70 years.
- KPS greater than or equal to 60.
- ALT and AST are less than 3 times normal.
- Total bilirubin less than 1.5mg/dl(25.65umol/L).
- Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
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- Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
- No pleural effusion in lungs.
- Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
- Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.
- KIR mismatch between patient and umbilical cord blood.
- Volunteer to participate in the trial and sign the informed consent form.
Who cannot join
- Malignant tumor patient.
- Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
- Patients with HIV, HCV positive.
- Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
- Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
- Patients receiving anticoagulant therapy or with severe coagulation disorders.
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- According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
- Patients with allergies or history of allergies to biological agents used in this program.
- Lactating or pregnant women.
- Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
- Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
- Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
- Patients participate in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Hospital of Shandong University
Jinan, Shandong, 250033
Chengyun Zheng, Ph.D., +86-531-85875502, chengyun.zheng@ki.se
About this study
Official title: Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.
- Conditions
- MDS-EB
- Being tested
- Allogeneic NK cell regimen group
- Keywords
- NK cell MDS-EB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic NK cell regimen groupBiological
10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen.
Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13，d15 .
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | 10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen. Receives: Biological: Allogeneic NK cell regimen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) (PR+CR)
The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes
Measured: 3 months
Secondary outcomes (1)
Overall survival(OS)
The proportion of patients with overall survival(OS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDS-EBStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengyun Zheng, Ph.D., Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599426
- Sponsor's protocol ID
- 2020.NK.MDS-EB
- Status last verified
- Oct 2020
- First submitted
- 11 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB
- ClinicalTrials.gov ID
- NCT04599426
- Acronym / sponsor ID
- 2020.NK.MDS-EB
- Conditions
- MDS-EB
- Keywords
- NK cell MDS-EB
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: Allogeneic NK cell regimen group10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
- Patients with age 15 years to 70 years.
- KPS greater than or equal to 60.
- ALT and AST are less than 3 times normal.
- Total bilirubin less than 1.5mg/dl(25.65umol/L).
Key exclusion criteria (13 listed)
- Malignant tumor patient.
- Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
- Patients with HIV, HCV positive.
- Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
- Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic NK cell regimen group10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen. Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13，d15 . | Biological | Test Group |
Primary outcome
Objective Response Rate (ORR) (PR+CR)
Time frame: 3 months
The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes
1 secondary outcome
Overall survival(OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chengyun Zheng, Ph.D. study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic NK cell regimen group in people with MDS-EB, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengyun Zheng, Ph.D. (+86-531-85875502, chengyun.zheng@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (PR+CR) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.