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Trial Title:
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk MDS
NCT ID:
NCT06109064
Condition:
Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Unrelated Umbilical Cord Blood
Description:
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10,
same blood type.
Arm group label:
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on
days 3 to 21)
Arm group label:
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
Intervention type:
Drug
Intervention name:
Decetabine
Description:
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)
Arm group label:
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
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)
Arm group label:
chemotherapy+Unrelated Umbilical Cord Blood microtransplantation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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
2. Patients aged 14-80, gender and race are not limited;
3. Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status
≤ 2;
4. Expected survival time ≥ 3 months;
5. 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%);
6. The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
7. Patients who voluntarily participate in this clinical study and have signed an
informed consent.
Exclusion Criteria:
1. Patients who have suffered from malignant tumors;
2. Patients have suffered from hematopoietic failure after chemotherapy, and have
undergone ineffective blood transfusion with unknown cause;
3. Patients who have undergone Class II or above surgery within 4 weeks prior to
enrollment;
4. Suffering from life-threatening diseases other than MDS;
5. Allergic to the drugs in the research;
6. 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;
7. Patients with test positive for HIV, HCV or HBV;
8. Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
9. Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for
anticoagulation;
10. Patients with mental illnesses or cognitive impairments;
11. Patients have participated within the month prior to enrollment or patients are
currently participating in other clinical trials;
12. There are other conditions that the investigators consider inappropriate for
inclusion.
Gender:
All
Minimum age:
14 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyu Zhu, MD
Phone:
15255456091
Email:
xiaoyuz@ustc.edu.cn
Start date:
October 27, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109064
