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This trial is a prospective, single-arm, single-center clinical study. A total of 44 elderly (aged 60 to 69 years) patients with hematological malignancies who need to receive a single-unit unrelated umbilical cord blood transplantation (UCBT) are planned to be enrolled. After screening and enrollment, patients are scheduled to receive the following drug treatment regimen: Thiotepa 5 mg/kg every 12 hours on day -8; Granulocyte Colony-Stimulating Factor(G-CSF) 5 ug/kg/day from day -8 to -5; Cytarabine 1.5 g/m2 from day -7 to -5; Fludarabine 30 mg/m2/day from day -7 to -4; Busulfan 0.8 mg/kg every 6 hours from day -4 to -2. Umbilical cord blood hematopoietic stem cells are reinfused on day 0. Routine monitoring of blood routine is conducted, and platelets and red blood cells are transfused when necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thiotepa + fludarabine + G-CSF + cytarabine + busulfan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiotepa | Drug | Thiotepa 5 mg/kg every 12 hours, D-8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 180-day non-recurrence mortality rate | 180-day |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative implantation rate of neutrophils | One month after the transplantation | |
| The cumulative implantation rate of platelets | One month after the transplantation | |
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Inclusion Criteria:
Aged between 60 and 69 years old (inclusive), gender not restricted.
Patients with hematological malignancies who plan to receive a single unrelated umbilical cord blood transplantation treatment
The liver and kidney functions, as well as the heart and lung functions, must meet the following requirements:
ECOG PS≤2
HCT-CI≤2
Expected survival period ≥ 6 months
By signing the informed consent form, one voluntarily participates in this study and is willing and able to cooperate with the data collection in this research.
Exclusion Criteria:
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| Fludarabine | Drug | Fludarabine 30 mg/m2 per day, from D-7 to -4. |
|
| G-CSF | Drug | G-CSF 5 ug/kg per day, from D-8 to D-5. |
|
| cytarabine | Drug | Cytarabine 1.5 g/m2, from D-7 to D-5. |
|
| busulfan | Drug | Busulfan 0.8 mg/kg, every 6 hours, from D-4 to -2. |
|
| The cumulative implantation time of platelets |
| One month after the transplantation |
| The cumulative implantation time of neutrophils | One month after the transplantation |
| The cumulative incidence and severity of acute and chronic graft-versus-host disease (GVHD) | Two years after the transplantation |
| One-year overall survival rate after transplantation | One year after transplantation |
| One-year progression-free survival rate after transplantation | One-year after transplantation |
| The cumulative recurrence rate one year after transplantation | one year after transplantation |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D013852 | Thiotepa |
| C024352 | fludarabine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003561 | Cytarabine |
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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