Relapsed or Refractory Acute Myeloid Leukemia (AML)NCT07500753
A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients
A study testing Allogeneic Hematopoietic Stem Cell Transplantation in people with Relapsed or Refractory Acute Myeloid Leukemia (AML) and MDS (Myelodysplastic Syndrome), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is one of the most common hematologic malignancies. With increasing life expectancy and the aging of society, the incidence of AML in the elderly population is rising. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia (AML), MDS (Myelodysplastic Syndrome)
- What is being tested?
- Allogeneic Hematopoietic Stem Cell Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jun 2029
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50years.
- Meet the 2022 World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML),MDS, and be diagnosed with relapsed/refractory AML after treatment, fulfilling any of the following definitions:
- Relapsed AML: Reappearance of leukemic cells in peripheral blood, bone marrow blasts >5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemic cells after achieving complete remission (CR or CRi).
- Refractory AML: Newly diagnosed cases that failed to respond after 2 courses of standard therapy; patients who relapsed within 12 months after consolidation therapy following CR; patients who relapsed after 12 months but failed to respond to conventional chemotherapy; patients with 2 or more relapses; persistent extramedullary leukemia.
- MDS:Myelodysplastic Neoplasms (MDS)MDS are a group of clonal hematopoietic stem cell disorders characterized by: Dysplastic hematopoiesis (abnormal development of blood cells in the bone marrow); Cytopenias (one or more lineages of blood cells are reduced in number); Increased risk of transformation to acute myeloid leukemia (AML).Key diagnostic criteria (per WHO 2022 classification): Persistent cytopenia(s) for ≥4 months (unless specific genetic abnormalities are present); Morphological dysplasia in ≥10% of cells in one or more lineages; Presence of MDS-defining genetic abnormalities (e.g., SF3B1 mutation, isolated del(5q), TP53 biallelic alteration).
- Cardiac, hepatic, and renal function test results within the following limits:
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- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);Total bilirubin ≤ 3 × ULN;Serum creatinine ≤ 2 × ULN or creatinine clearance ≥ 40 mL/min;Left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scan within the normal range (>50%).
- Have a suitable allogeneic donor.
- Expected survival ≥ 1 month.
- Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- The patient understands the study protocol and voluntarily signs the informed consent form.
Who cannot join
- Patients had serious adverse reactions to investigational drugs such as allergies;
- Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
- Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;
- Patients received Class II or higher surgery within 4 weeks prior to enrollment;
- Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;
- Patient has active central nervous system leukemia infiltration;
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- Pregnant or lactating patients;
- Patient is currently participating in another clinical studies;
- Other conditions where the investigator deems the patient unsuitable for inclusion.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Single-arm, Prospective Study of a Cladribine-Bridged Lisaftolax and Busulfan Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Myelodysplastic Syndromes and Acute Myeloid Leukemia in Elderly Patients
Acute myeloid leukemia (AML) is one of the most common hematologic malignancies. With increasing life expectancy and the aging of society, the incidence of AML in the elderly population is rising. The prognosis of elderly AML patients is significantly worse than that of younger patients: the 5-year overall survival rate in patients over 60 years is less than 20%, while the median survival in patients over 80 years is only 3-6 months . Improving the overall prognosis of elderly AML has become a hot topic in current hematology research.
Hematopoietic stem cell transplantation (HSCT) is a therapeutic approach that involves intravenous infusion of hematopoietic stem cells with the goal of restoring bone marrow and immune function. Although several studies have focused on allo-HSCT in elderly patients, factors affecting transplant outcomes remain controversial, influencing clinical decision-making. Julian et al. retrospectively analyzed 103 elderly patients with relapsed/refractory AML who underwent allogeneic transplantation, showing that high-dose melphalan sequential chemotherapy was effective and well tolerated in elderly AML patients, with a 3-year overall survival rate exceeding 40%; disease prognosis was closely related to donor source and pre-transplant leukemic burden . Furthermore, studies on haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients are limited. A retrospective analysis from Peking University People's Hospital involving 199 elderly AML patients (≥50 years) who underwent allo-HSCT confirmed that haplo-HSCT is feasible in elderly AML patients; however, transplantation in a refractory/active disease state was associated with poorer transplant outcomes. A study from the EBMT summarized outcomes in 360 elderly patients (≥70 years) who underwent allogeneic transplantation in a non-remission state, reporting 2-year overall survival rates of 25.9%, 43%, and 62.4% for haplo-HSCT, unrelated donor, and matched sibling donor transplants, respectively.
Read more
The challenge in treating relapsed/refractory elderly AML patients lies in improving the tolerability of conditioning regimens and reducing conditioning-related toxicity, thereby increasing the success rate of transplantation. Venetoclax (VEN), an orally administered selective small-molecule B-cell lymphoma 2 (BCL-2) inhibitor, has demonstrated efficacy in randomized clinical trials across several hematologic malignancies. As monotherapy for relapsed/refractory AML, VEN shows modest efficacy while exhibiting good tolerability . In the global phase III clinical trial of venetoclax, in newly diagnosed AML patients unfit for intensive induction chemotherapy, venetoclax combined with azacitidine demonstrated significantly superior clinical efficacy compared to azacitidine alone, with a response rate (CR+CRi) more than three times higher than that of the control group, enabling patients to achieve faster and deeper remissions. Our center has also accumulated extensive experience with venetoclax in post-transplant maintenance therapy for AML and in the treatment of relapsed/refractory AML. Additionally, studies have confirmed the safety and efficacy of high-dose venetoclax in newly diagnosed AML . Based on the aforementioned clinical efficacy and theoretical rationale, our center previously conducted a study investigating the venetoclax + azacitidine + busulfan (VABu) regimen in allogeneic HSCT for elderly AML patients, confirming that this novel regimen reduces conditioning-related chemotherapy toxicity, improves tolerability, and demonstrates advantages in decreasing cardiotoxicity, mucositis, infections, and organ dysfunction. Lisaftolax, as a second-generation BCL-2 inhibitor, can partially overcome venetoclax resistance and improve patient outcomes.
Nevertheless, a consensus on the comprehensive systemic treatment strategy for elderly AML patients has not yet been reached globally. For high-risk or relapsed/refractory elderly AML patients, after risk stratification and assessment of response to chemotherapy, those who are suitable for allo-HSCT may receive a conditioning regimen consisting of cladribine bridged to lisaftolax and busulfan (Clad/LABu), aiming to achieve longer remission duration, reduce post-transplant relapse rates, and improve long-term survival in elderly AML patients.
Read the detailed description
The aim of this study is to observe the efficacy-related factors and adverse events of the Clad-LABU regimen as conditioning for allogeneic hematopoietic stem cell transplantation in patients with relapsed/refractory MDS/AML in Elderly Patients
- Being tested
- Allogeneic Hematopoietic Stem Cell Transplantation
- Keywords
- Conditioning Regimen, Relapsed or Refractory Acute Myeloid Leukemia, Cladribine, Lisaftolax, Busulfan, Allogeneic Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Clad+LABU Conditioning Regimen :Cladribine: 6.0 mg/m² once daily for 3 days, intravenous infusion on days -14 to -12;Cytarabine (Ara-C): 1.0 g/m² once daily for 3 days, intravenous infusion on days -14 to -12;Lomustine (CCNU): 250 mg/m² once on day -11, orally;Lisaftoclax: 1200 mg once daily for 6 days, orally on days -11 to -6;Azacitidine (AZA): 75 mg/m² once daily for 5 days, subcutaneous injection on days -10 to -6.
Alternatively, or Decitabine (DAC): 20 mg/m² once daily for 5 days, intravenous infusion on days -10 to -6;Busulfan: 0.8 mg/kg every 6 hours for 3 days, intravenous infusion on days -5 to -3.
| Study group | Role | What they receive |
|---|---|---|
| 30 patients with relapsed/refractory MDS/AML who undergo HSCT | Experimental | patients undergo HSCT using Clad-LABu as a conditioning regimen Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival rate
Relapse-Free Survival (RFS) is defined as the time from transplantation until disease relapse or death from any cause, whichever occurs first.
Measured: within 1 year following HSCT
Overall survival rate
We estimated OS from the time of transplant until the date of death of any cause or last follow-up for patients still alive.
Measured: within 1 year following HSCT
Secondary outcomes (4)
The cumulative incidence of neutrophil engraftment and platelet engraftment
Neutrophil and platelet engraftment is defined as the first occurrence of 3 consecutive days with an absolute neutrophil count of at least 0.5×109/L and a platelet count of over 20×109/L for 7 consecutive days without transfusion support.
Measured: on day 28±7 following HSCT]
The cumulative incidence of transplant-related mortality (TRM)
Transplant-related mortality was defined as mortality due to any cause other than disease progression within 100 days of transplantation.
Measured: within 100 days following HSCT
The cumulative incidence and grade of graft-versus-host disease (GVHD)
Graft-versus-host disease (GVHD) is a medical complication following the receipt of transplanted tissue from a genetically different person.
Measured: within 1 year following HSCT
The cumulative incidence of relapse
We defined relapse as any clinical evidence of progression or recurrence of original diseases.
Measured: within 1 year following HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Acute Myeloid Leukemia (AML)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Depei Wu, Study chair, The First Affiliated Hospital of Soochow UniversityXiaojin Wu, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500753
- Sponsor's protocol ID
- SOOCHOW-WXJ-2025-1293
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Study of a Cladribine-Bridged Lisaftolax and Busulfan Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Myelodysplastic Syndromes and Acute Myeloid Leukemia in Elderly Patients
- ClinicalTrials.gov ID
- NCT07500753
- Acronym / sponsor ID
- SOOCHOW-WXJ-2025-1293
- Keywords
- Conditioning Regimen, Relapsed or Refractory Acute Myeloid Leukemia, Cladribine, Lisaftolax, Busulfan, Allogeneic Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 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.
Acute myeloid leukemia (AML) is one of the most common hematologic malignancies. With increasing life expectancy and the aging of society, the incidence of AML in the elderly population is rising. The prognosis of elderly AML patients is significantly worse than that of younger patients: the 5-year overall survival rate in patients over 60 years is less than 20%, while the median survival in patients over 80 years is only 3-6 months . Improving the overall prognosis of elderly AML has become a hot topic in current hematology research.
Hematopoietic stem cell transplantation (HSCT) is a therapeutic approach that involves intravenous infusion of hematopoietic stem cells with the goal of restoring bone marrow and immune function. Although several studies have focused on allo-HSCT in elderly patients, factors affecting transplant outcomes remain controversial, influencing clinical decision-making. Julian et al. retrospectively analyzed 103 elderly patients with relapsed/refractory AML who underwent allogeneic transplantation, showing that high-dose melphalan sequential chemotherapy was effective and well tolerated in elderly AML patients, with a 3-year overall survival rate exceeding 40%; disease prognosis was closely related to donor source and pre-transplant leukemic burden . Furthermore, studies on haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients are limited. A retrospective analysis from Peking University People's Hospital involving 199 elderly AML patients (≥50 years) who underwent allo-HSCT confirmed that haplo-HSCT is feasible in elderly AML patients; however, transplantation in a refractory/active disease state was associated with poorer transplant outcomes. A study from the EBMT summarized outcomes in 360 elderly patients (≥70 years) who underwent allogeneic transplantation in a non-remission state, reporting 2-year overall survival rates of 25.9%, 43%, and 62.4% for haplo-HSCT, unrelated donor, and matched sibling donor transplants, respectively.
The challenge in treating relapsed/refractory elderly AML patients lies in improving the tolerability of conditioning regimens and reducing conditioning-related toxicity, thereby increasing the success rate of transplantation. Venetoclax (VEN), an orally administered selective small-molecule B-cell lymphoma 2 (BCL-2) inhibitor, has demonstrated efficacy in randomized clinical trials across several hematologic malignancies. As monotherapy for relapsed/refractory AML, VEN shows modest efficacy while exhibiting good tolerability . In the global phase III clinical trial of venetoclax, in newly diagnosed AML patients unfit for intensive induction chemotherapy, venetoclax combined with azacitidine demonstrated significantly superior clinical efficacy compared to azacitidine alone, with a response rate (CR+CRi) more than three times higher than that of the control group, enabling patients to achieve faster and deeper remissions. Our center has also accumulated extensive experience with venetoclax in post-transplant maintenance therapy for AML and in the treatment of relapsed/refractory AML. Additionally, studies have confirmed the safety and efficacy of high-dose venetoclax in newly diagnosed AML . Based on the aforementioned clinical efficacy and theoretical rationale, our center previously conducted a study investigating the venetoclax + azacitidine + busulfan (VABu) regimen in allogeneic HSCT for elderly AML patients, confirming that this novel regimen reduces conditioning-related chemotherapy toxicity, improves tolerability, and demonstrates advantages in decreasing cardiotoxicity, mucositis, infections, and organ dysfunction. Lisaftolax, as a second-generation BCL-2 inhibitor, can partially overcome venetoclax resistance and improve patient outcomes.
Nevertheless, a consensus on the comprehensive systemic treatment strategy for elderly AML patients has not yet been reached globally. For high-risk or relapsed/refractory elderly AML patients, after risk stratification and assessment of response to chemotherapy, those who are suitable for allo-HSCT may receive a conditioning regimen consisting of cladribine bridged to lisaftolax and busulfan (Clad/LABu), aiming to achieve longer remission duration, reduce post-transplant relapse rates, and improve long-term survival in elderly AML patients.
Detailed description
The aim of this study is to observe the efficacy-related factors and adverse events of the Clad-LABU regimen as conditioning for allogeneic hematopoietic stem cell transplantation in patients with relapsed/refractory MDS/AML in Elderly Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 patients with relapsed/refractory MDS/AML who undergo HSCT | Experimental | Procedure: Allogeneic Hematopoietic Stem Cell Transplantationpatients undergo HSCT using Clad-LABu as a conditioning regimen |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 50years.
- Meet the 2022 World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML),MDS, and be diagnosed with relapsed/refractory AML after treatment, fulfilling any of the following definitions:
- Relapsed AML: Reappearance of leukemic cells in peripheral blood, bone marrow blasts >5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemic cells after achieving complete remission (CR or CRi).
- Refractory AML: Newly diagnosed cases that failed to respond after 2 courses of standard therapy; patients who relapsed within 12 months after consolidation therapy following CR; patients who relapsed after 12 months but failed to respond to conventional chemotherapy; patients with 2 or more relapses; persistent extramedullary leukemia.
- MDS:Myelodysplastic Neoplasms (MDS)MDS are a group of clonal hematopoietic stem cell disorders characterized by: Dysplastic hematopoiesis (abnormal development of blood cells in the bone marrow); Cytopenias (one or more lineages of blood cells are reduced in number); Increased risk of transformation to acute myeloid leukemia (AML).Key diagnostic criteria (per WHO 2022 classification): Persistent cytopenia(s) for ≥4 months (unless specific genetic abnormalities are present); Morphological dysplasia in ≥10% of cells in one or more lineages; Presence of MDS-defining genetic abnormalities (e.g., SF3B1 mutation, isolated del(5q), TP53 biallelic alteration).
Key exclusion criteria (9 listed)
- Patients had serious adverse reactions to investigational drugs such as allergies;
- Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
- Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;
- Patients received Class II or higher surgery within 4 weeks prior to enrollment;
- Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;
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 |
|---|---|---|
| Allogeneic Hematopoietic Stem Cell TransplantationClad+LABU Conditioning Regimen :Cladribine: 6.0 mg/m² once daily for 3 days, intravenous infusion on days -14 to -12;Cytarabine (Ara-C): 1.0 g/m² once daily for 3 days, intravenous infusion on days -14 to -12;Lomustine (CCNU): 250 mg/m² once on day -11, orally;Lisaftoclax: 1200 mg once daily for 6 days, orally on days -11 to -6;Azacitidine (AZA): 75 mg/m² once daily for 5 days, subcutaneous injection on days -10 to -6. Alternatively, or Decitabine (DAC): 20 mg/m² once daily for 5 days, intravenous infusion on days -10 to -6;Busulfan: 0.8 mg/kg every 6 hours for 3 days, intravenous infusion on days -5 to -3. | Procedure or surgery | 30 patients with relapsed/refractory MDS/AML who undergo HSCT |
Primary outcome
Relapse free survival rate
Time frame: within 1 year following HSCT
Relapse-Free Survival (RFS) is defined as the time from transplantation until disease relapse or death from any cause, whichever occurs first.
Overall survival rate
Time frame: within 1 year following HSCT
We estimated OS from the time of transplant until the date of death of any cause or last follow-up for patients still alive.
4 secondary outcomes
The cumulative incidence of neutrophil engraftment and platelet engraftment
Time frame: on day 28±7 following HSCT]
The cumulative incidence of transplant-related mortality (TRM)
Time frame: within 100 days following HSCT
The cumulative incidence and grade of graft-versus-host disease (GVHD)
Time frame: within 1 year following HSCT
The cumulative incidence of relapse
Time frame: within 1 year following HSCT
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 15 Apr 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.
Depei Wu study chair
The First Affiliated Hospital of Soochow University
Xiaojin Wu study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic Hematopoietic Stem Cell Transplantation in people with Relapsed or Refractory Acute Myeloid Leukemia (AML) and MDS (Myelodysplastic Syndrome), run by The First Affiliated Hospital of Soochow University 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 11 inclusion and 9 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 15 Apr 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.
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 Xiaojin Wu (+8613057493105, wuxiaojin@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival rate (time frame: within 1 year following HSCT). The study lists 2 primary outcomes in all. 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 15 Apr 2026.