Hematologic MalignanciesPhase 2NCT07441967
The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation
A Phase 2 study testing Thiotepa, Fludarabine and G-CSF in people with Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 69 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Thiotepa, Fludarabine and G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 12Show fewer
- 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.
Who cannot join
- 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
About this study
Official 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
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
- Being tested
- Thiotepa, Fludarabine, G-CSF, cytarabine, busulfan
- Keywords
- Unrelated Umbilical Cord Blood Transplantation, Regimen
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiotepaDrug
Thiotepa 5 mg/kg every 12 hours, D-8.
FludarabineDrug
Fludarabine 30 mg/m2 per day, from D-7 to -4.
G-CSFDrug
G-CSF 5 ug/kg per day, from D-8 to D-5.
cytarabineDrug
Cytarabine 1.5 g/m2, from D-7 to D-5.
busulfanDrug
Busulfan 0.8 mg/kg, every 6 hours, from D-4 to -2.
| Study group | Role | What they receive |
|---|---|---|
| Thiotepa + fludarabine + G-CSF + cytarabine + busulfan | Experimental | Not described Receives: Drug: Thiotepa; Drug: Fludarabine; Drug: G-CSF; Drug: cytarabine; Drug: busulfan |
What is being measured
The primary outcome is the main question the study is designed to answer.
180-day non-recurrence mortality rate
Measured: 180-day
Secondary outcomes (8)
The cumulative implantation rate of neutrophils
Measured: One month after the transplantation
The cumulative implantation rate of platelets
Measured: One month after the transplantation
The cumulative implantation time of platelets
Measured: One month after the transplantation
The cumulative implantation time of neutrophils
Measured: One month after the transplantation
The cumulative incidence and severity of acute and chronic graft-versus-host disease (GVHD)
Measured: Two years after the transplantation
One-year overall survival rate after transplantation
Measured: One year after transplantation
One-year progression-free survival rate after transplantation
Measured: One-year after transplantation
The cumulative recurrence rate one year after transplantation
Measured: one year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start20 Feb 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441967
- Sponsor's protocol ID
- IIT2025140
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07441967
- Acronym / sponsor ID
- IIT2025140
- Conditions
- Hematologic Malignancies
- Keywords
- Unrelated Umbilical Cord Blood Transplantation, Regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thiotepa + fludarabine + G-CSF + cytarabine + busulfan | Experimental | Drug: Thiotepa, Drug: Fludarabine, Drug: G-CSF, Drug: cytarabine, Drug: busulfan |
Who may qualify
- Ages
- 60 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiotepaThiotepa 5 mg/kg every 12 hours, D-8. | Drug | Thiotepa + fludarabine + G-CSF + cytarabine + busulfan |
| FludarabineFludarabine 30 mg/m2 per day, from D-7 to -4. | Drug | Thiotepa + fludarabine + G-CSF + cytarabine + busulfan |
| G-CSFG-CSF 5 ug/kg per day, from D-8 to D-5. | Drug | Thiotepa + fludarabine + G-CSF + cytarabine + busulfan |
| cytarabineCytarabine 1.5 g/m2, from D-7 to D-5. | Drug | Thiotepa + fludarabine + G-CSF + cytarabine + busulfan |
| busulfanBusulfan 0.8 mg/kg, every 6 hours, from D-4 to -2. | Drug | Thiotepa + fludarabine + G-CSF + cytarabine + busulfan |
Primary outcome
180-day non-recurrence mortality rate
Time frame: 180-day
8 secondary outcomes
The cumulative implantation rate of neutrophils
Time frame: One month after the transplantation
The cumulative implantation rate of platelets
Time frame: One month after the transplantation
The cumulative implantation time of platelets
Time frame: One month after the transplantation
The cumulative implantation time of neutrophils
Time frame: One month after the transplantation
The cumulative incidence and severity of acute and chronic graft-versus-host disease (GVHD)
Time frame: Two years after the transplantation
One-year overall survival rate after transplantation
Time frame: One year after transplantation
One-year progression-free survival rate after transplantation
Time frame: One-year after transplantation
The cumulative recurrence rate one year after transplantation
Time frame: one year after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Related trials for Hematologic Malignancies
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thiotepa, Fludarabine and G-CSF in people with Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180-day non-recurrence mortality rate (time frame: 180-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.