The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation

NCT07441967 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT2025140
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hematologic Malignancies

Keywords

Unrelated Umbilical Cord Blood Transplantation; Regimen

Outcome Measures

Primary Outcomes (1)

• 180-day non-recurrence mortality rate

  180-day

Secondary Outcomes (8)

• The cumulative implantation rate of neutrophils

  One month after the transplantation

• The cumulative implantation rate of platelets

  One month after the transplantation

• 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

Study Arms (1)

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

EXPERIMENTAL

Drug: Thiotepa; Drug: Fludarabine; Drug: G-CSF; Drug: cytarabine; Drug: busulfan

Interventions

Thiotepa DRUG

Thiotepa 5 mg/kg every 12 hours, D-8.

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

Fludarabine DRUG

Fludarabine 30 mg/m2 per day, from D-7 to -4.

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

G-CSF DRUG

G-CSF 5 ug/kg per day, from D-8 to D-5.

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

cytarabine DRUG

Cytarabine 1.5 g/m2, from D-7 to D-5.

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

busulfan DRUG

Busulfan 0.8 mg/kg, every 6 hours, from D-4 to -2.

Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

Eligibility Criteria

• Age: 60 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Serum creatinine ≤ 1.5 × ULN
• Cardiac function: Ejection fraction \> 50%
• Baseline oxygen saturation \> 92%
• Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
• Pulmonary function: DLCO (hemoglobin-corrected) \> 65% and FEV1 \> 65%
• 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.

You may not qualify if:

• For those who are allergic to the drugs and their related metabolites
• Any unstable systemic diseases: including but not limited to stable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification ≥ 3), severe arrhythmias requiring drug treatment, liver, kidney or metabolic diseases; patients with pulmonary hypertension; or diseases that, in the judgment of the investigator, pose a serious threat to the safety of the patient or affect the patient's ability to complete the study.
• Active and uncontrolled infection: Hemodynamic instability related to the infection, or new symptoms or signs of infection appear, or new infection lesions are found on imaging, or persistent fever without symptoms or signs that cannot rule out the presence of an infection.
• The patient is currently involved in a clinical intervention study
• The patient is unable to understand the nature of the study or has not given informed consent

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Thiotepa; fludarabine; Granulocyte Colony-Stimulating Factor; Cytarabine; Busulfan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 2, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02