- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105658
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML
A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xiaoyu Zhu, MD
- Phone Number: 15255456091
- Email: xiaoyuz@ustc.edu.cn
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230001
- Recruiting
- The First Affiliated Hospital of University of Science and Technology of China
-
Contact:
- Xiaoyu Zhu, MD
- Phone Number: 15255456091
- Email: xiaoyuz@ustc.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:
Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).
Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;
- 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.
Exclusion Criteria:
- 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 AML;
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy+unrelated umbilical cord blood microtransplantation
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".
|
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)
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)
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response (CR) rate
Time Frame: 28±7days
|
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. |
28±7days
|
Hematopoietic recovery time
Time Frame: 28±7days
|
The time of absolute neutrophil count>0.5×10^9/L
and platelet count >30×10^9/L for 3 consecutive days.
|
28±7days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression(TTP)
Time Frame: 1 year
|
Time from enrollment to objective progression of disease
|
1 year
|
Disease Free Survival(DFS)
Time Frame: 1 year
|
From CR to recurrence or death or to the date of last follow-up
|
1 year
|
Overall Survival(OS)
Time Frame: 1 year
|
From the beginning of treatment to death or to the date of last follow-up
|
1 year
|
Early mortality rate
Time Frame: 3 months
|
Death within the first 3 months of induction therapy
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in lymphocyte subsets (NK cells, T cells) before and after treatment
Time Frame: At the time of enrollment and at 1 month
|
The concentration of lymphocyte subsets in peripheral blood can be detected by flow cytometry
|
At the time of enrollment and at 1 month
|
Correlation between human leukocyte antigen (HLA) matching and the concentration of lymphocyte subsets
Time Frame: HLA typing and matching will be assessed at the time of enrollment, and the concentration of lymphocyte subsets in peripheral blood will be detected at the time of enrollment and at 1 month
|
HLA typing and matching can be assessed by sequence based genotyping (PCR-SBT), and the concentration of lymphocyte subsets in peripheral blood can be detected by flow cytometry
|
HLA typing and matching will be assessed at the time of enrollment, and the concentration of lymphocyte subsets in peripheral blood will be detected at the time of enrollment and at 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaoyu Zhu, MD, The First Affiliated Hospital of University of Science and Technology of China
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCB-MST&AML
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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