ALL (Acute B-Lymphoblastic Leukemia)NCT07297576
Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation
A study testing Sulforaphane in people with ALL (Acute B-Lymphoblastic Leukemia) and AML (Acute Myelogenous Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myelogenous Leukemia, MDS (Myelodysplastic Syndrome)
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to Jun 2027
- Phase
- Interventional
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 with high-risk haematological malignancies: including AML, ALL, high-risk MDS
- Age: ≥18 years
- Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points
- Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4/6, 7/10 and CD34 cells ≥0.83×105/kg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.
Who cannot join
- Patients who test positive for the following pathogens: HIV (HIV-1/2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).
- Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening
- Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation
- Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients
- Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)
- Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research
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- History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT > 3 × ULN; total serum bilirubin > 2.5 × ULN; total bilirubin > 3 × ULN and direct bilirubin > 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction ("LVEF") < 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) <45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR <60mL/min/1.73m2 and direct bilirubin >1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1/FVC <60% and/or diffusion function <60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.
- Uncorrectable coagulation disorders or history of severe bleeding disorders
- Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation
- Known allergy to the test drug or ingredients
- Have participated or are participating in other interventional clinical studies within 3 months prior to screening
- Live vaccination within 6 weeks prior to screening
- Pregnant or breastfeeding women
- Subjects did not follow the study protocol well
- Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial
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
Institute of Hematology, Blood Diseases Hospital
Tianjing
Zimin Sun, 86-22-23909492, sunzimin@ihcams.ac.cn
About this study
Official title: Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study
Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. By March 2025 China's seven (eight) public cord blood stem cell banks had frozen more than 280,000 public umbilical cord blood, while the percentage of those frozen for ≥10 years was 26%, making clinical application a concern. The previous study showed that long-term freezing impairs cellular mitochondrial function leading to decreased reconstruction of cord blood haematopoietic stem progenitor cells and impaired differentiation into the megakaryotic lineage, and that intervention with the antioxidant radicicol thiols (SFN) can partially rescue the cellular functional damage caused by freezing. The findings were based on immunodeficient animals, and clinical studies are urgently needed to determine whether SFN intervention can promote post-transplant haematopoietic reconstitution in patients with long term cryopreserved (≥10 years) UCB. In this project, the investigators propose to conduct a single-arm, open, single-centre phase I-II clinical study on the safety and feasibility of dietary supplement SFN to promote early haematopoietic restoration after cord blood transplantation to evaluate the safety and feasibility of the use of long-frozen UCB for peri-infusion SFN use in adult transplant recipients, and to reveal the effect of peri-infusion SFN use on neutrophil implantation. This project will provide scientific guidance to promote the clinical application of long-term cryopreserved UCB, as well as key data to optimise the clinical transplantation strategy of UCB and expand its application.
Read the detailed description
Please see the detailed description in following content
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myelogenous Leukemia, MDS (Myelodysplastic Syndrome)
- Being tested
- Sulforaphane
- Medical subject headings
- 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.
SulforaphaneDietary supplement
For the Aspirin arm, 30mg/tablet of the antioxidant substance radicicolothionein for oral administration, 2 tablets each time, three times a day; unrelated umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | For the Aspirin arm, 30mg/tablet of the antioxidant substance radicicolothionein for oral administration, two tablets each time, three times a day; unrelated umbilical cord Receives: Dietary Supplement: Sulforaphane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the occurrence of adverse events, including non-haematological adverse events of grade 3 or higher
Based on CTCAE (Common Terminology Criteria for Adverse Events) grading, determine the need for dose reduction or suspension of medication; observe the incidence of transplant-related complications acute GVHD, the incidence of infections, the transplant-related mortality Rate (TRM)
Measured: 2 months post-transplant
Time to neutrophil recovery after UCBT
Blood routine test
Measured: 3 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start22 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL (Acute B-Lymphoblastic Leukemia)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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Dong, Principal investigator, Institute of Hematology & Blood Diseases Hospital, Tianjin, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297576
- Sponsor's protocol ID
- IIT2025085
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No