Safety IssuesPhase 1NCT04174586
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
A Phase 1 study testing microtransplantation in people with Safety Issues and Efficiency, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Safety Issues, Efficiency
- What is being tested?
- microtransplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2020to 31 Aug 2024
- Phase
- Phase 1
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- de novo acute myeloid leukemia
- age 60-80
Who cannot join
- have no suitable donor or donor refused
- patient refused to accept donor cells
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of USTC
Hefei, 230001
Wen Yao, 055162283730 ext. 055162283730, yaowen0511@163.com
About this study
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia
Read the detailed description
The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)
- Conditions
- Safety Issues, Efficiency
- Being tested
- microtransplantation
- Keywords
- Cord blood microtransplatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microtransplantationBiological
HLA mismatched donor cord blood infusion
| Study group | Role | What they receive |
|---|---|---|
| cord blood group | Experimental | standard induction and consolidation chemotherapy with cord blood microtransplantation Receives: Biological: microtransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.
Measured: 1 month
time of hematopoietic recovery
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Measured: 1 month
Secondary outcomes (1)
time to progression
Measured from complete remission to the relapse
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start22 Jan 2020
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zimin Sun, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174586
- Sponsor's protocol ID
- CB-001
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04174586
- Acronym / sponsor ID
- CB-001
- Conditions
- Safety Issues, Efficiency
- Keywords
- Cord blood microtransplatation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Nov 2019 (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.
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia
Detailed description
The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cord blood group | Experimental | Biological: microtransplantationstandard induction and consolidation chemotherapy with cord blood microtransplantation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- de novo acute myeloid leukemia
- age 60-80
Key exclusion criteria (2 listed)
- have no suitable donor or donor refused
- patient refused to accept donor cells
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 |
|---|---|---|
| microtransplantationHLA mismatched donor cord blood infusion | Biological | cord blood group |
Primary outcome
complete remission rate
Time frame: 1 month
Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease.
time of hematopoietic recovery
Time frame: 1 month
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
1 secondary outcome
time to progression
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Zimin Sun study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing microtransplantation in people with Safety Issues and Efficiency, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 2 inclusion and 2 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 26 Mar 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 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.
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 Wen Yao (055162283730 ext. 055162283730, yaowen0511@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: 1 month). The study lists 2 primary outcomes in all. 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 26 Mar 2020.