A Phase 2 interventional study of Thiotepa and Fludarabine in Acute Leukemia, High Risk, Acute Leukemia Refractory and Acute Leukemia, Relapsed, sponsored by Guangdong Second Provincial General Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Guangdong Second Provincial General Hospital · Phase 2, Interventional, and Treatment
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.
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.
Guangdong Second Provincial General Hospital is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Drug: Thiotepa · Drug: Fludarabine · Drug: Etoposide · Radiation: Total Body Irradiation (TBI) · Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Thiotepa, 5 mg/kg/day by intravenous infusion on Days -5 and -4; total dose 10 mg/kg.
Fludarabine, 30 mg/m²/day by intravenous infusion on Days -5, -4, and -3; total dose 90 mg/m².
Etoposide (VP-16), 15 mg/kg/day by intravenous infusion on Days -3 and -2; total dose 30 mg/kg.
Total body irradiation at 4.5 Gy once daily on Days -7 and -6; total dose 9 Gy.
First allo-HSCT after the conditioning regimen, using a suitable HLA-matched, haploidentical, or unrelated donor.
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.
Time frame: From date of allo-HSCT until relapse or death from any cause, assessed up to 1year.
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.
Time frame: At Day +28 after allo-HSCT
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.
Time frame: At Day +28 after allo-HSCT
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.
Time frame: Up to 100 days after stem cell infusion
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.
Time frame: Up to 100 days after stem cell infusion
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.
Time frame: Up to 100 days after stem cell infusion
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.
Time frame: From first conditioning drug dose through 24 months after allo-HSCT; assessed at 6, 12, and 24 months after transplant
Cumulative Incidence of Leukemia Relapse
Cumulative incidence of leukemia relapse, with non-relapse death treated as a competing event.
Time frame: From first conditioning drug dose through 24 months after allo-HSCT
Cumulative Incidence of Non-Relapse Mortality
Cumulative incidence of death without preceding leukemia relapse, with relapse treated as a competing event.
Time frame: From first conditioning drug dose through 24 months after allo-HSCT
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.
Time frame: From allo-HSCT through 24 months after transplantation
Incidence of Acute Graft-Versus-Host Disease
Proportion of transplant recipients with acute graft-versus-host disease within 100 days after transplantation.
Time frame: Through Day +100 after allo-HSCT
Incidence of Chronic Graft-Versus-Host Disease
Proportion of transplant recipients with chronic graft-versus-host disease during follow-up after transplantation.
Time frame: From Day +101 through 24 months after allo-HSCT
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.
Time frame: From first conditioning drug dose through Day +100 after allo-HSCT
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.
Time frame: From conditioning initiation through Day +100 after allo-HSCT，assessed up to 100 days.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Thiotepa · Fludarabine · Etoposide
Guangdong Second Provincial General Hospital