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Acute Leukemia, High RiskPhase 2NCT07920796

Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia

A Phase 2 study testing Thiotepa, Fludarabine and Etoposide in people with Acute Leukemia, High Risk and Acute Leukemia Refractory, run by Guangdong Second Provincial General Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study is a multi-center, prospective, single-arm clinical trial, with 50 participants expected to take part in it. The primary objective of this study is to assess the efficacy and safety of a conditioning regimen comprising thiotepa combined with TBI, fludarabine, and etoposide for allo-HSCT in patients with R/R… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Thiotepa, Fludarabine and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
16 Jun 2026to 31 Jul 2029
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Written informed consent.
  • Age 18-60 years, inclusive.
  • Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed-phenotype acute leukemia according to the diagnostic criteria specified in the protocol.
  • Relapsed/refractory disease or high-risk AML/ALL according to the protocol-defined criteria (AML risk referencing ELN 2017; ALL risk referencing NCCN 2024).
  • Willingness to undergo first allo-HSCT with a suitable HLA-matched, haploidentical, or unrelated donor.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Adequate organ function: ALT, AST, and total bilirubin ≤2 × upper limit of normal (ULN); serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min; left ventricular ejection fraction ≥50%; and FEV1/FVC ≥60%.

Who cannot join

  • Previous allo-HSCT.
  • Uncontrolled severe infection before transplantation, including sepsis or active tuberculosis.
  • Severe cardiac or pulmonary dysfunction that, in the investigator's judgment, precludes the proposed conditioning regimen.
  • Severe hepatic dysfunction (ALT, AST, or total bilirubin >2 × ULN) or severe renal dysfunction (serum creatinine >1.5 × ULN and creatinine clearance <50 mL/min), judged by the investigator to preclude conditioning.
  • Pregnancy or breastfeeding.
  • Any other condition that, in the investigator's judgment, makes participation unsuitable, such as poor adherence or a psychiatric condition.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Department of Hematology, Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Thiotepa Combined With TBI, Fludarabine, and Etoposide as Intensive Pre-treatment for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory/Recurrent or High-risk Acute Leukemia: a Multi-center, Prospective, Single-arm Clinical Study

This study is a multi-center, prospective, single-arm clinical trial, with 50 participants expected to take part in it. The primary objective of this study is to assess the efficacy and safety of a conditioning regimen comprising thiotepa combined with TBI, fludarabine, and etoposide for allo-HSCT in patients with R/R acute leukemia or those at high risk for such disease. The secondary objective is to explore the prognosis and benefits for different subgroups of patients with acute leukemia, taking into account their clinical characteristics.

Read the detailed description

After signing the informed consent form, the subjects completed the screening evaluation 3 days before enrollment, and those who met the inclusion and exclusion criteria received the established enhanced pretreatment regimen combined with allo HSCT. The subjects will undergo regular bone marrow and systemic examinations to assess the primary disease and safety until 24 months after transplantation.

After screening and enrollment, the patient received a combination of cetriptyline, TBI, fludarabine, and etoposide enhanced pretreatment regimen:

Whole body irradiation (TBI) 4.5 Gy/time, total dose 9 Gy, pre transplant -7 to -6 days (once a day); Cetriptyline (TT) 5mg/kg/day, total dose 10mg/kg, administered from -5 to -4 days before transplantation (divided into 2 days); Fludarabine (Flu) 30mg/m ²/d, total dose 90mg/m ², administered from -5 to -3 days before transplantation (divided into 3 days); Etoposide (VP16) 15mg/kg/day, total dose 30mg/kg, pre transplant -3 days to -2 days (divided into 2 days).

Allow the use of G-CSF or TPO drugs to promote hematopoietic stem cell implantation. Routine monitoring of blood routine, and necessary infusion of platelets and red blood cells.

Each subject will undergo regular bone marrow and whole-body examinations for primary disease assessment before and after transplantation. The time points for primary disease assessment are: once a month before enrollment and within the first 3 months after transplantation, once every 2 months from the 4th to the 9th month after transplantation, and then every 3 months until the 24th month after transplantation. At the same time, each subject underwent safety assessment every 3 days from enrollment until hematopoietic reconstruction after transplantation. Safety assessment was conducted once a week from hematopoietic reconstruction to the third month after transplantation, and then once a month until the 12th month after transplantation. Follow up was conducted every 2 months until the 24th month after transplantation.

Keywords
acute leukemia, high risk, relapsed/refractory, Intensive conditioning
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThiotepaDrug

    Thiotepa, 5 mg/kg/day by intravenous infusion on Days -5 and -4; total dose 10 mg/kg.

  • FludarabineDrug

    Fludarabine, 30 mg/m²/day by intravenous infusion on Days -5, -4, and -3; total dose 90 mg/m².

  • EtoposideDrug

    Etoposide (VP-16), 15 mg/kg/day by intravenous infusion on Days -3 and -2; total dose 30 mg/kg.

  • Total Body Irradiation (TBI)Radiation

    Total body irradiation at 4.5 Gy once daily on Days -7 and -6; total dose 9 Gy.

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    First allo-HSCT after the conditioning regimen, using a suitable HLA-matched, haploidentical, or unrelated donor.

Study groups in NCT07920796
Study groupRoleWhat they receive
Thiotepa/TBI/Fludarabine/Etoposide Conditioning Plus Allo-HSCTExperimentalParticipants receive total body irradiation, thiotepa, fludarabine, and etoposide on prespecified days before their first allogeneic hematopoietic stem cell transplantation, followed by protocol-specified assessments through 24 months after transplantation.
Receives: Drug: Thiotepa; Drug: Fludarabine; Drug: Etoposide; Radiation: Total Body Irradiation (TBI); Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. One-Year Disease-Free Survival Rate After Allogeneic Transplantation

    Proportion of participants alive without leukemia relapse at 1 year after allo-HSCT; relapse or death from any cause is an event.

    Measured: From date of allo-HSCT until relapse or death from any cause, assessed up to 1year.

Secondary outcomes (13)

  1. Complete Remission or Complete Remission With Incomplete Hematologic Recovery Rate at Day +28

    Proportion of evaluable participants in complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) at Day +28 after transplantation, based on protocol-defined blood, bone marrow, and extramedullary disease criteria.

    Measured: At Day +28 after allo-HSCT

  2. Minimal Residual Disease Conversion-to-Negative Rate at Day +28

    Proportion of evaluable participants whose minimal residual disease (MRD) status converts to negative by Day +28 after transplantation.

    Measured: At Day +28 after allo-HSCT

  3. Time to Neutrophil Engraftment

    Number of days from stem cell infusion to the first of 3 consecutive days with an absolute neutrophil count >0.5 × 10⁹/L.

    Measured: Up to 100 days after stem cell infusion

  4. Time to Platelet Engraftment

    Number of days from stem cell infusion to the first day of a 7-day period with a platelet count >20 × 10⁹/L without platelet transfusion.

    Measured: Up to 100 days after stem cell infusion

  5. Time to Hemoglobin Recovery

    Number of days from stem cell infusion to the first day of a 7-day period with hemoglobin >70 g/L without red blood cell transfusion.

    Measured: Up to 100 days after stem cell infusion

  6. Overall Survival at 6, 12, and 24 Months After Allo-HSCT

    Kaplan-Meier estimate of the probability of survival at each prespecified post-transplant time point. Overall survival is measured from the first conditioning drug dose to death from any cause; participants not known to have died are censored at the last known date alive.

    Measured: From first conditioning drug dose through 24 months after allo-HSCT; assessed at 6, 12, and 24 months after transplant

  7. Cumulative Incidence of Leukemia Relapse

    Cumulative incidence of leukemia relapse, with non-relapse death treated as a competing event.

    Measured: From first conditioning drug dose through 24 months after allo-HSCT

  8. Cumulative Incidence of Non-Relapse Mortality

    Cumulative incidence of death without preceding leukemia relapse, with relapse treated as a competing event.

    Measured: From first conditioning drug dose through 24 months after allo-HSCT

  9. Graft-Versus-Host Disease-Free, Relapse-Free Survival

    Probability of being alive without grade II-IV acute graft-versus-host disease or moderate-severe chronic graft-versus-host disease, leukemia relapse after transplantation.

    Measured: From allo-HSCT through 24 months after transplantation

  10. Incidence of Acute Graft-Versus-Host Disease

    Proportion of transplant recipients with acute graft-versus-host disease within 100 days after transplantation.

    Measured: Through Day +100 after allo-HSCT

  11. Incidence of Chronic Graft-Versus-Host Disease

    Proportion of transplant recipients with chronic graft-versus-host disease during follow-up after transplantation.

    Measured: From Day +101 through 24 months after allo-HSCT

  12. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

    Number and proportion of participants with treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, and serious adverse events, classified using NCI CTCAE version 5.0.

    Measured: From first conditioning drug dose through Day +100 after allo-HSCT

  13. Incidence of Conditioning-Related Organ Toxicity

    Number and proportion of participants with organ toxicity assessed as directly related to conditioning, excluding graft-versus-host disease, bleeding, and infection.

    Measured: From conditioning initiation through Day +100 after allo-HSCT，assessed up to 100 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start16 Jun 2026
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920796
Sponsor's protocol ID
2026-KY-KZ-193-02
Status last verified
Nov 2026
First submitted
19 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thiotepa, Fludarabine and Etoposide in people with Acute Leukemia, High Risk and Acute Leukemia Refractory, run by Guangdong Second Provincial General Hospital at 1 site in 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 7 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

One-Year Disease-Free Survival Rate After Allogeneic Transplantation (time frame: From date of allo-HSCT until relapse or death from any cause, assessed up to 1year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07920796.

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 6 Nov 2026.

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