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

NCT ID: NCT06105658

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-02-01

Brief 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.

Conditions

Acute Myelocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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".

Group Type: EXPERIMENTAL

Unrelated umbilical cord blood

Intervention Type: BIOLOGICAL

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

Venetoclax

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Interventions

Unrelated umbilical cord blood

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

Intervention Type: BIOLOGICAL

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Zhu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyu Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of University of Science and Technology of China

Locations

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyu Zhu, MD

Role: CONTACT

xiaoyuz@ustc.edu.cn

15255456091

Facility Contacts

Xiaoyu Zhu, MD

Role: primary

xiaoyuz@ustc.edu.cn

15255456091

Other Identifiers

UCB-MST&AML

Identifier Type: -

Identifier Source: org_study_id