Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
NCT07920796, Phase 2, Enrolling by invitation, Guangdong Second Provincial General Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia | ClinicalTrials.gov |
| NCT number | NCT07920796 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Guangdong Second Provincial General Hospital | ClinicalTrials.gov |
| Conditions | Acute Leukemia, High Risk, Acute Leukemia Refractory, Acute Leukemia, Relapsed | ClinicalTrials.gov |
| Interventions | Thiotepa, Fludarabine, Etoposide, Total Body Irradiation (TBI), Allogeneic Hematopoietic Stem Cell Transplantation | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | One-Year Disease-Free Survival Rate After Allogeneic Transplantation | From date of allo-HSCT until relapse or death from any cause, assessed up to 1year. | Proportion of participants alive without leukemia relapse at 1 year after allo-HSCT; relapse or death from any cause is an event. | ClinicalTrials.gov |
| Secondary | Complete Remission or Complete Remission With Incomplete Hematologic Recovery Rate at Day +28 | At Day +28 after allo-HSCT | 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. | ClinicalTrials.gov |
| Secondary | Minimal Residual Disease Conversion-to-Negative Rate at Day +28 | At Day +28 after allo-HSCT | Proportion of evaluable participants whose minimal residual disease (MRD) status converts to negative by Day +28 after transplantation. | ClinicalTrials.gov |
| Secondary | Time to Neutrophil Engraftment | Up to 100 days after stem cell infusion | Number of days from stem cell infusion to the first of 3 consecutive days with an absolute neutrophil count \>0.5 × 10⁹/L. | ClinicalTrials.gov |
| Secondary | Time to Platelet Engraftment | Up to 100 days after stem cell infusion | 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. | ClinicalTrials.gov |
| Secondary | Time to Hemoglobin Recovery | Up to 100 days after stem cell infusion | 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. | ClinicalTrials.gov |
| Secondary | Overall Survival at 6, 12, and 24 Months After Allo-HSCT | From first conditioning drug dose through 24 months after allo-HSCT; assessed at 6, 12, and 24 months after transplant | 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. | ClinicalTrials.gov |
| Secondary | Cumulative Incidence of Leukemia Relapse | From first conditioning drug dose through 24 months after allo-HSCT | Cumulative incidence of leukemia relapse, with non-relapse death treated as a competing event. | ClinicalTrials.gov |
| Secondary | Cumulative Incidence of Non-Relapse Mortality | From first conditioning drug dose through 24 months after allo-HSCT | Cumulative incidence of death without preceding leukemia relapse, with relapse treated as a competing event. | ClinicalTrials.gov |
| Secondary | Graft-Versus-Host Disease-Free, Relapse-Free Survival | From allo-HSCT through 24 months after transplantation | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Acute Graft-Versus-Host Disease | Through Day +100 after allo-HSCT | Proportion of transplant recipients with acute graft-versus-host disease within 100 days after transplantation. | ClinicalTrials.gov |
| Secondary | Incidence of Chronic Graft-Versus-Host Disease | From Day +101 through 24 months after allo-HSCT | Proportion of transplant recipients with chronic graft-versus-host disease during follow-up after transplantation. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events | From first conditioning drug dose through Day +100 after allo-HSCT | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Conditioning-Related Organ Toxicity | From conditioning initiation through Day +100 after allo-HSCT，assessed up to 100 days. | Number and proportion of participants with organ toxicity assessed as directly related to conditioning, excluding graft-versus-host disease, bleeding, and infection. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)