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NCT Number: NCT07441967

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

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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Key information

Conditions

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

Age range

60 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

  • 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
  • Other circumstances where the researcher deems the patient unsuitable for inclusion in this study

Treatment and study plan

Thiotepa

Drug

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

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.

Primary outcomes

  1. 180-day non-recurrence mortality rate

    Time frame: 180-day

Secondary outcomes

  1. The cumulative implantation rate of neutrophils

    Time frame: One month after the transplantation

  2. The cumulative implantation rate of platelets

    Time frame: One month after the transplantation

  3. The cumulative implantation time of platelets

    Time frame: One month after the transplantation

  4. The cumulative implantation time of neutrophils

    Time frame: One month after the transplantation

  5. The cumulative incidence and severity of acute and chronic graft-versus-host disease (GVHD)

    Time frame: Two years after the transplantation

  6. One-year overall survival rate after transplantation

    Time frame: One year after transplantation

  7. One-year progression-free survival rate after transplantation

    Time frame: One-year after transplantation

  8. The cumulative recurrence rate one year after transplantation

    Time frame: one year after transplantation

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Prospective, Single-arm, Single-center, Open-label Clinical Study on the Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation for Elderly Patients With Hematologic Malignancies

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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