Acute Lymphocytic Leukemia (ALL)Phase 1NCT07565220
Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
A Phase 1 study testing Thiotepa, Fludarabine and Busulfan in people with Acute Lymphocytic Leukemia (ALL) and Acute Myeloid Leukemia (AML), run by Sawa Ito, MD at 1 site in United States.
Trial summary
This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Acute Leukemia
- What is being tested?
- Thiotepa, Fludarabine and Busulfan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to 1 Nov 2030
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:
- Age 50-70 years old or
- Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician
- Patients have one of the following diagnoses:
- Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (<5% marrow blasts by morphology).
- Acute myeloid leukemia (AML) in first or subsequent morphological remission (<5% marrow blasts by morphology) with or without hematologic recovery.
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- Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia or chronic myeloid leukemia with blast crisis) in first or subsequent morphological remission (<5% marrow blasts by morphology) with or without hematologic recovery.
- Myelodysplastic syndrome (MDS) with a history of excess blasts, with >5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor, cytoreductive chemotherapy.
- High-risk myeloproliferative neoplasm (MPN) with no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.
- Patients with an 8/8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)
- Provision of signed and dated informed consent form
- Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy for GVHD is discontinued (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
- Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
- Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria.
- For high-intensity regimen:
- Poor performance status with Karnofsky Score <70%
- Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score >5
- Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.
- Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.
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- Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.
- Patients with organ dysfunction, including:
- Renal insufficiency creatinine clearance <45 ml/min/1.72m2 measured by 24-hr urine specimen
- Left ventricular ejection fraction <45%
- Diffusing capacity of the lung for carbon monoxide (DLCO) corrected <50% or FEV1 <50%
- Liver function abnormality: total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.
- Patients who have received previous allogeneic transplantation.
- Patients with a life expectancy <12 months due to co-existing diseases other than hematologic malignancies.
- Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
- Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).
- Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.
- For low-intensity regimen
- Poor performance status with Karnofsky Score <60%
- Patients with active CNS involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.
- Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.
- Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.
- Patients with organ dysfunction, including:
- Renal insufficiency creatinine clearance <40 ml/min/1.72m2 measured by 24-hr urine specimen
- Left ventricular ejection fraction <40%
- DLCO corrected< 50% or FEV1<50%
- Liver function abnormality: total bilirubin, AST, ALT>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.
- Patients who have received previous allogeneic transplantation.
- Patients with a life expectancy <12 months from co-existing disease other than hematologic malignancies
- Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
- Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).
- Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
Amy Rogers, RN, BSN, 412-623-4036, rodgera@upmc.edu
Linda Elias, RN, BSN, 412-623-6037, eliaslj@upmc.edu
About this study
Official title: Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
Read the detailed description
Allogeneic stem cell transplantation (alloSCT) offers potential curative therapy for individuals with high-risk hematologic malignancies. Establishing appropriate immune tolerance between donor and recipient is essential to prevent graft-versus-host disease (GVHD) and graft rejection. Over the past decade, the introduction of post-graft cyclophosphamide (PTCy) as an immune-tolerance-inducing strategy has substantially reshaped the alloSCT landscape.
This trial aims to optimize the PTCy regimen through two primary approaches: 1) de-escalation of PTCy dosing to reduce toxicities, and 2) incorporation of thiotepa to strengthen anti-leukemia activity. The central hypothesis is that regimen optimization will improve transplant outcomes-particularly graft-versus-host disease and relapse-free survival (GRFS)-for recipients of HLA-matched donor alloSCT with high-risk hematologic malignancies. An exploratory objective will evaluate pre-transplant biomarkers capable of stratifying toxicity and relapse risk, enabling personalization of regimen intensity for each transplant recipient.
- Conditions
- Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Acute Leukemia, Myelodysplastic Syndrome(MDS), Myeloproliferative Neoplasm (MPN)
- Being tested
- Thiotepa, Fludarabine, Busulfan, PBSC infusion
- Keywords
- allogeneic hematopoietic stem cell transplantation, HLA, graft-versus-host disease (GVHD)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myeloproliferative Disorders, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiotepaDrug
Also called Tepadina
Thiotepa is an alkylating agent used in combination with other chemotherapy agents to treat cancer.
FludarabineDrug
Fludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia. It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, results in the inhibition of DNA synthesis, and destroys the cancer cells.
BusulfanDrug
Busulfan is a chemotherapy drug used in preparation for a stem cell transplant.
PBSC infusionProcedure or surgery
Peripheral Blood Stem Cell (PBSC) infusion is a medical procedure used to replace diseased or damaged stem cells in patients, particularly after cancer treatments.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: T1FluBu2 (low-intensity) | Experimental | Thiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 30 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0 Receives: Drug: Thiotepa; Drug: Fludarabine; Drug: Busulfan; Procedure: PBSC infusion |
| Cohort 2: T2FluBu2 (high-intensity) | Experimental | Thiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 40 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0 Receives: Drug: Thiotepa; Drug: Fludarabine; Drug: Busulfan; Procedure: PBSC infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD-free, relapse-free survival (GRFS)
Graft Versus Host Disease (GVHD)-free, relapse-free survival (GRFS) is defined by survival without a qualifying event including Death, Relapse of primary disease, Grade III-IV acute graft-versus-host disease (GVHD), graded via MAGIC criteria, Chronic moderate or severe GVHD requiring systemic immunosuppression, graded via NIH consensus criteria.
Measured: At 1 year
Secondary outcomes (10)
Median time to neutrophil engraftment
Median time to neutrophil engraftment will be defined as the median number of days from transplant at which the cumulative engraftment rate reaches 50%.
Measured: Up to 30 days
Median time to platelet engraftment
Median number of days from transplant at which the cumulative engraftment rate of platelet recovery to 20,000/mm3 and 50,000/mm3 reaches 50% respectively.
Measured: Up to 30 days
Frequency of severe mucositis
Percentage of patients experiencing severe mucositis, defined as grade 3-4 by WHO criteria.
Measured: Up to 30 days post-transplant
Frequency of total parental nutrition
Percentage of patients who require TPN at any time from the start of conditioning through day +30 post-transplant.
Measured: Up to 30 days post-transplant
Frequency of severe pulmonary complications requiring ICU-level support
Percentage of patients with first occurrence of any respiratory failure, severe infectious lower respiratory tract infection, or noninfectious acute lung injury, requiring ICU-level support between Day 0 and Day +30 after stem cell infusion. ICU-level support is defined by either 1) ICU admission due to respiratory failure, 2) need for new non-invasive ventilation (BiPAP or CPAP), or 3) requirement of high-flow nasal cannula >30L/min at FiO2>40%.
Measured: Up to 30 days
Cumulative incidence of infectious disease complications
Cumulative incidence of all Grade II and higher infections will be reported according to Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) Infection Grading Criteria. The BMT CTN grading system provides a standardized approach for capturing and monitoring infectious complications in clinical trials.
Measured: Up to 1-year post-transplant
Cumulative incidence of thrombotic microangiopathy
- . Microangiopathic hemolytic anemia, defined by: a. Evidence of schistocytes on peripheral blood smear, and b. Elevated lactate dehydrogenase (LDH) above the upper limit of normal, and c. Decreased haptoglobin or other laboratory evidence of hemolysis (e.g., indirect hyperbilirubinemia), and d. Negative Coombs (direct antiglobulin) test.
- Thrombocytopenia: a. New or progressive thrombocytopenia not explained by disease relapse, infection, drug effect, or disseminated intravascular coagulation (DIC).
- Renal and/or neurologic dysfunction temporally associated with hemolysis, not fully explained by other causes: a. Rising serum creatinine or new/worsening hypertension, and/or b. New-onset or worsening neurologic signs/symptoms (e.g., confusion, seizures, focal deficits).
- No alternative explanation: a. ADAMTS13 activity not suggestive of TTP (if available) and clinical evaluation not consistent with DIC, severe sepsis, or malignant hypertension as the primary cause.
Measured: Up to 180 days post-transplant
Grade III-IV acute GVHD-free survival
Time from date of stem cell infusion to the first occurrence of grade III or IV acute Graft Versus Host Disease (GVHD), with follow-up through 100 days post-transplant or death.
Measured: Up to 100 days post-transplant
Moderate to severe chronic GVHD-free survival
Time from date of stem cell infusion to the first occurrence of moderate-to-severe chronic Graft Versus Host Disease (GVHD) with follow up through 1-year post-transplant or death.
Measured: At 1 year1 year post-transplant
Primary graft failure
Failure to achieve an absolute neutrophil count (ANC) > 0.5 x 109/L by day +42 after stem cell infusion.
Measured: Up to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start27 Jul 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic Leukemia (ALL)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sawa Ito, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sawa Ito, MD, University of Pittsburgh
- Investigators
- Sawa M Ito, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565220
- Sponsor's protocol ID
- HCC 26-008
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07565220
- Acronym / sponsor ID
- HCC 26-008
- Conditions
- Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Acute Leukemia, Myelodysplastic Syndrome(MDS), Myeloproliferative Neoplasm (MPN)
- Keywords
- allogeneic hematopoietic stem cell transplantation, HLA, graft-versus-host disease (GVHD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sawa Ito, MDUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 4 May 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 phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
Detailed description
Allogeneic stem cell transplantation (alloSCT) offers potential curative therapy for individuals with high-risk hematologic malignancies. Establishing appropriate immune tolerance between donor and recipient is essential to prevent graft-versus-host disease (GVHD) and graft rejection. Over the past decade, the introduction of post-graft cyclophosphamide (PTCy) as an immune-tolerance-inducing strategy has substantially reshaped the alloSCT landscape.
This trial aims to optimize the PTCy regimen through two primary approaches: 1) de-escalation of PTCy dosing to reduce toxicities, and 2) incorporation of thiotepa to strengthen anti-leukemia activity. The central hypothesis is that regimen optimization will improve transplant outcomes-particularly graft-versus-host disease and relapse-free survival (GRFS)-for recipients of HLA-matched donor alloSCT with high-risk hematologic malignancies. An exploratory objective will evaluate pre-transplant biomarkers capable of stratifying toxicity and relapse risk, enabling personalization of regimen intensity for each transplant recipient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: T1FluBu2 (low-intensity) | Experimental | Drug: Thiotepa, Drug: Fludarabine, Drug: Busulfan, Procedure: PBSC infusionThiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 30 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0 |
| Cohort 2: T2FluBu2 (high-intensity) | Experimental | Drug: Thiotepa, Drug: Fludarabine, Drug: Busulfan, Procedure: PBSC infusionThiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 40 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:
- Patients have one of the following diagnoses:
- Patients with an 8/8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)
- Provision of signed and dated informed consent form
- Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy for GVHD is discontinued (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
Key exclusion criteria (32 listed)
- Subjects will be excluded from the study if they meet any of the following criteria.
- Poor performance status with Karnofsky Score <70%
- Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score >5
- Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.
- Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.
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 |
|---|---|---|
| ThiotepaAlso: TepadinaThiotepa is an alkylating agent used in combination with other chemotherapy agents to treat cancer. | Drug | Cohort 1: T1FluBu2 (low-intensity), Cohort 2: T2FluBu2 (high-intensity) |
| FludarabineFludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia. It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, results in the inhibition of DNA synthesis, and destroys the cancer cells. | Drug | Cohort 1: T1FluBu2 (low-intensity), Cohort 2: T2FluBu2 (high-intensity) |
| BusulfanBusulfan is a chemotherapy drug used in preparation for a stem cell transplant. | Drug | Cohort 1: T1FluBu2 (low-intensity), Cohort 2: T2FluBu2 (high-intensity) |
| PBSC infusionPeripheral Blood Stem Cell (PBSC) infusion is a medical procedure used to replace diseased or damaged stem cells in patients, particularly after cancer treatments. | Procedure or surgery | Cohort 1: T1FluBu2 (low-intensity), Cohort 2: T2FluBu2 (high-intensity) |
Primary outcome
GVHD-free, relapse-free survival (GRFS)
Time frame: At 1 year
Graft Versus Host Disease (GVHD)-free, relapse-free survival (GRFS) is defined by survival without a qualifying event including Death, Relapse of primary disease, Grade III-IV acute graft-versus-host disease (GVHD), graded via MAGIC criteria, Chronic moderate or severe GVHD requiring systemic immunosuppression, graded via NIH consensus criteria.
10 secondary outcomes
Median time to neutrophil engraftment
Time frame: Up to 30 days
Median time to platelet engraftment
Time frame: Up to 30 days
Frequency of severe mucositis
Time frame: Up to 30 days post-transplant
Frequency of total parental nutrition
Time frame: Up to 30 days post-transplant
Frequency of severe pulmonary complications requiring ICU-level support
Time frame: Up to 30 days
Cumulative incidence of infectious disease complications
Time frame: Up to 1-year post-transplant
Cumulative incidence of thrombotic microangiopathy
Time frame: Up to 180 days post-transplant
Grade III-IV acute GVHD-free survival
Time frame: Up to 100 days post-transplant
Moderate to severe chronic GVHD-free survival
Time frame: At 1 year1 year post-transplant
Primary graft failure
Time frame: Up to Day 42
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Sawa M Ito, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thiotepa, Fludarabine and Busulfan in people with Acute Lymphocytic Leukemia (ALL) and Acute Myeloid Leukemia (AML), run by Sawa Ito, MD at 1 site in United States.
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 14 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 18 Aug 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Amy Rogers, RN, BSN (412-623-4036, rodgera@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD-free, relapse-free survival (GRFS) (time frame: At 1 year). 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 18 Aug 2026.