Myelodysplastic SyndromesPhase 2NCT06109064

Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk MDS

A Phase 2 study testing Unrelated Umbilical Cord Blood, Venetoclax and Decetabine in people with Myelodysplastic Syndromes, run by Anhui Provincial Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of above-mentioned MDS patients by observing the factors related to the efficacy and adverse reactions. Read more about this study

Who is it for?: Ages 14 to 80 years
Conditions the study is for: Myelodysplastic Syndromes
What is being tested?: Unrelated Umbilical Cord Blood, Venetoclax and Decetabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteChina
Study dates: 27 Oct 2023to 1 Feb 2026
Phase: Phase 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 14 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients diagnosed with MDS with WHO criteria through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Patients can be newly diagnosed, recurrent or unresponsive, with International prognostic scoring system (IPSS-R) score> 3.5
Patients aged 14-80, gender and race are not limited;
Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Expected survival time ≥ 3 months;
The examination results meet the following requirements:
ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (>50%);
The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
Patients who voluntarily participate in this clinical study and have signed an informed consent.

Who cannot join

Patients who have suffered from malignant tumors;
Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
Suffering from life-threatening diseases other than MDS;
Allergic to the drugs in the research;
Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;

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Patients with test positive for HIV, HCV or HBV;
Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
Patients with mental illnesses or cognitive impairments;
Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
There are other conditions that the investigators consider inappropriate for inclusion.

Trial locations and contacts

1 site in 1 country.

Xiaoyu Zhu, MD contact

15255456091

xiaoyuz@ustc.edu.cn

China1 site, 1 recruiting

The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Xiaoyu Zhu, MD, 15255456091, xiaoyuz@ustc.edu.cn
Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk Myelodysplastic Syndromes

Conditions: Myelodysplastic Syndromes
Being tested: Unrelated Umbilical Cord Blood, Venetoclax, Decetabine, Azacitidine
Medical subject headings: Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unrelated Umbilical Cord BloodBiological
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.
VenetoclaxDrug
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)
DecetabineDrug
Patients will be treated with Decetabine (20mg/m^2/d on days 1 to 5) or Azacitidine (75mg/m^2/d on days 1 to 7)
AzacitidineDrug
Patients will be treated with Decetabine (20mg/m^2/d on days 1 to 5) or Azacitidine (75mg/m^2/d on days 1 to 7)

Study groups in NCT06109064
Study group	Role	What they receive
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation	Experimental	Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation" Receives: Biological: Unrelated Umbilical Cord Blood; Drug: Venetoclax; Drug: Decetabine; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete response (CR) rate
CR rate is defined as the percentage of patients who met the following conditions:
Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count > 1.0×10^9/L, platelet count > 100×10^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion.
Measured: 28±7 days
Hematopoietic recovery time
The time of absolute neutrophil count>0.5×10^9/L and platelet count >30×10^9/L for 3 consecutive days.
Measured: 28±7 days

Secondary outcomes (4)

Time to Progression（TTP）
Time from enrollment to objective progression of disease
Measured: 1 year
Disease Free Survival（DFS）
From CR to recurrence or death or to the date of last follow-up
Measured: 1 year
Overall Survival（OS）
From the beginning of treatment to death or to the date of last follow-up
Measured: 1 year
Early mortality rate
Death within the first 3 months of induction therapy
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20231 Feb 2026

First posted31 Oct 2023
Study start27 Oct 2023 (estimated)
Primary completion1 Feb 2024 (estimated)
Study completion1 Feb 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06109064
Sponsor's protocol ID: UCB-MST&MDS
Status last verified: Oct 2023
First submitted: 19 Oct 2023
Last updated: 31 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Xiaoyu Zhu, MD

15255456091

xiaoyuz@ustc.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Myelodysplastic Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT06109064
Acronym / sponsor ID: UCB-MST&MDS
Conditions: Myelodysplastic Syndromes
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 14 participants (estimated)
Lead sponsor: Anhui Provincial HospitalOther government
Study start: 27 Oct 2023 (estimated)
Primary completion: 1 Feb 2024 (estimated)
Study completion: 1 Feb 2026 (estimated)
First posted: 31 Oct 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation	Experimental	Biological: Unrelated Umbilical Cord Blood, Drug: Venetoclax, Drug: Decetabine, Drug: AzacitidineIntermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation"

Who may qualify

Ages: 14 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Patients diagnosed with MDS with WHO criteria through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Patients can be newly diagnosed, recurrent or unresponsive, with International prognostic scoring system (IPSS-R) score> 3.5
Patients aged 14-80, gender and race are not limited;
Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Expected survival time ≥ 3 months;
The examination results meet the following requirements:

Key exclusion criteria (12 listed)

Patients who have suffered from malignant tumors;
Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
Suffering from life-threatening diseases other than MDS;
Allergic to the drugs in the research;

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
Unrelated Umbilical Cord BloodThe requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.	Biological	chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
VenetoclaxPatients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)	Drug	chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
DecetabinePatients will be treated with Decetabine (20mg/m^2/d on days 1 to 5) or Azacitidine (75mg/m^2/d on days 1 to 7)	Drug	chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
AzacitidinePatients will be treated with Decetabine (20mg/m^2/d on days 1 to 5) or Azacitidine (75mg/m^2/d on days 1 to 7)	Drug	chemotherapy+Unrelated Umbilical Cord Blood microtransplantation

Primary outcome

Complete response (CR) rate
Time frame: 28±7 days
CR rate is defined as the percentage of patients who met the following conditions: Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count > 1.0×10^9/L, platelet count > 100×10^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion.
Hematopoietic recovery time
Time frame: 28±7 days
The time of absolute neutrophil count>0.5×10^9/L and platelet count >30×10^9/L for 3 consecutive days.

4 secondary outcomes

Time to Progression（TTP）
Time frame: 1 year
Disease Free Survival（DFS）
Time frame: 1 year
Overall Survival（OS）
Time frame: 1 year
Early mortality rate
Time frame: 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.

Related trials for Myelodysplastic Syndromes

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

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.

Xiaoyu Zhu, MD contact

15255456091

xiaoyuz@ustc.edu.cn

Xiaoyu Zhu, MD principal investigator

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 2 study testing Unrelated Umbilical Cord Blood, Venetoclax and Decetabine in people with Myelodysplastic Syndromes, run by Anhui Provincial Hospital 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 8 inclusion and 12 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 31 Oct 2023. 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 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 Xiaoyu Zhu, MD (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: 28±7 days). 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?

On the ClinicalTrials.gov record for NCT06109064.

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 31 Oct 2023.