Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

Acute Myelocytic Leukemia Clinical Trial

Official title:

A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105658
• Other study ID #: UCB-MST&AML
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: Anhui Provincial Hospital
• Contact: Xiaoyu Zhu, MD
• Phone: 15255456091
• Email: xiaoyuz[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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 AML;

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.

Related Conditions & MeSH terms

• Acute Myelocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• Unrelated umbilical cord blood
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.

Drug:
• Venetoclax
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)
• Decetabine
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)
• Azacitidine
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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in lymphocyte subsets (NK cells, T cells) before and after treatment	The concentration of lymphocyte subsets in peripheral blood can be detected by flow cytometry	At the time of enrollment and at 1 month
Other	Correlation between human leukocyte antigen (HLA) matching and the concentration of lymphocyte subsets	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
Primary	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.	28±7days
Primary	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.	28±7days
Secondary	Time to Progression(TTP)	Time from enrollment to objective progression of disease	1 year
Secondary	Disease Free Survival(DFS)	From CR to recurrence or death or to the date of last follow-up	1 year
Secondary	Overall Survival(OS)	From the beginning of treatment to death or to the date of last follow-up	1 year
Secondary	Early mortality rate	Death within the first 3 months of induction therapy	3 months