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An Open, Single Center, Randomized Controlled Clinical Study of UCB (Cord Blood) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

An Open, Single Center, Randomized Controlled Clinical Study of UCB (Cord Blood) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05577611
Enrollment
57
Registered
2022-10-13
Start date
2022-08-10
Completion date
2024-12-25
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

UCB (Cord Blood) Microtransplantation in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Keywords

acute myeloid leukemia, cord blood, HSCT

Brief summary

In recent years, the curative effect of AML has been greatly improved. However, 20% - 30% of young patients and 40% - 50% of old patients will relapse again. Its re induction response rate is low, the survival period is short, and the prognosis is very poor. At present, there is no standard treatment scheme. Although a small number of patients can benefit from allogeneic hematopoietic stem cell transplantation (allo HSCT), most patients lack suitable donors. The choice of high-dose chemotherapy is a rescue treatment scheme, but the treatment-related hematology or non hematology related toxicity and high mortality make the scheme controversial, especially for the elderly. Some studies have proposed a new treatment method combining chemotherapy with peripheral blood hematopoietic stem cell infusion after mobilization of HLA mismatched donors. Preliminary clinical studies verified that after more than 70 cases of elderly acute myeloid leukemia were treated with microtransplantation, the complete remission rate reached 80%, the 2-year disease-free survival rate reached 39%, the early mortality rate was only 6.7%, and the median recovery time of neutrophils and platelets was 11 and 14.5 days, respectively, which was significantly different from the control group of chemotherapy alone. After that, the micro transplantation technology was extended to the treatment of myelodysplastic syndrome and lymphoma, and good results were also obtained. Compared with peripheral blood / bone marrow hematopoietic stem cells, umbilical cord blood (UCB) hematopoietic stem cells have the advantages of rapid access, convenient source, no harm to donors, and low requirements for HLA matching. The immune cells in cord blood hematopoietic stem cells are mostly Na ï ve and immature immune cells, so the incidence and severity of graft-versus-host disease (GVHD) after unrelated cord blood transplantation are low, which not only reduces the failure of transplantation due to GVHD, but also avoids a series of complications and high costs brought by complex GVHD prevention and treatment techniques. Because cord blood is rich in CD16 + CD56 + NK cells and CD3 + T cells, cord blood hematopoietic stem cell transplantation also plays an important role in GVL.

Interventions

COMBINATION_PRODUCTBasic chemotherapy + UCB transplantation

The basic chemotherapy regimen was the same as that of the control group UCB micro transplantation scheme: Aza 100mg, 75mg/m2/d, IVGTT, D-10 to D-4 Ara-C 1000mg/m2/q12h, IVGTT, D-3 to D-2 Single non consanguineous umbilical cord blood (NC \> 1.5 \* 10 \^ 7 / kg), IVGTT, D0 Bone marrow aspiration smear, MRD and bone marrow chimerism were detected on D14, d30 and D60 after transplantation.

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* No previous transplantation treatment; * Acute myeloid leukemia; * Karnofsky score ≥ 60%, physical strength status of Eastern Cooperative Oncology Group (ECoG) ≤ 2; * Cord blood with HLA matching 0-3 / 6 and blood type matching;

Exclusion criteria

* Second-class or above surgery within 4 weeks before randomization; * Currently diagnosed as malignant tumor other than AML or under treatment; * Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and acute transformation phase; * Stroke or intracranial hemorrhage occurred within 6 months before randomization; * Uncontrolled or symptomatic arrhythmias; * Congestive heart failure;Myocardial infarction within 6 months before screening; * Any grade 3 (moderate) or grade 4 (severe) heart disease (according to NYHA); * Active human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) Dependence on illicit drugs; * Mental or cognitive impairment; * Participate in other clinical trials 1 month before registration;

Design outcomes

Primary

MeasureTime frameDescription
Change from marrow blast in percentage at Week 18Day 0,Day 1,Week 1,Week4,Week 12,Week 18marrow blast in percentage
Change from Blood routine in plasma at Week 18Day 0,Day 1,Week 1,Week4,Week 12,Week 18WBC
Change from liver and kidney function at Week 18Day 0,Day 1,Week 1,Week4,Week 12,Week 18ALB
ECG QT Interval,ST segment,P wave,QPS wave groupDay 1We will record this index in the first day

Countries

China

Contacts

Primary ContactFuling Zhou
zhoufuling@163.com.cn18986265580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026