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New treatment option for MDS (Myelodysplastic Syndrome)
Official title Haplo-Cord HSCT for AML/MDS
ClinicalTrials.gov ID: NCT07588360
What this study is testing
What is Fludarabine, Cytarabine, Busulfan, Antithymocyte Globulin (ATG), Melphalan, Cyclophosphamide (CTX)?
Fludarabine, Cytarabine, Busulfan, Antithymocyte Globulin (ATG), Melphalan, Cyclophosphamide (CTX) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for mds (myelodysplastic syndrome).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the clinical efficacy of haploidentical-cord blood hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), and to analyze the impact of different engraftment patterns (haploidentical engraftment versus cord blood engraftment) on clinical outcomes. By comparing the efficacy of haploidentical-cord blood transplantation in different subtypes of AML and MDS, this research will explore its unique advantages and comparative effectiveness relative to conventional transplantation strategies, so as to provide new evidence for clinical practice.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 60
You may be able to join if
- Age between 14 and 60 years, with no gender restriction.
- Intermediate- or high-risk AML in first complete remission (CR1).
- AML in second or subsequent complete remission (≥ CR2).
- Relapsed or refractory AML.
- Low-risk AML meeting any of the following: Failure to achieve a ≥3-log reduction in RUNX1::RUNX1T1 transcript level compared with baseline after 2...
You likely can't join if
- Prior history of other hematopoietic stem cell transplantation.
- History of ex vivo T-cell-depleted stem cell transplantation.
- Survival duration of less than 1 month after transplantation.
- Severe organ dysfunction, including significant impairment of hepatic, renal, cardiac, or pulmonary function.
- Active severe infection, such as uncontrolled pneumonia, sepsis, or other systemic infections.
- History of severe hypersensitivity reactions to study medications, including cyclophosphamide or anti-thymocyte globulin (ATG).
See the full eligibility criteria
- Age between 14 and 60 years, with no gender restriction.
- Intermediate- or high-risk AML in first complete remission (CR1).
- AML in second or subsequent complete remission (≥ CR2).
- Relapsed or refractory AML.
- Low-risk AML meeting any of the following: Failure to achieve a ≥3-log reduction in RUNX1::RUNX1T1 transcript level compared with baseline after 2 consolidation cycles, or loss of major molecular remission (MMR) within...
- Intermediate-2 or high-risk MDS according to the IPSS scoring system.
- Adequate general health status and ability to tolerate hematopoietic stem cell transplantation.
- Provision of signed informed consent and willingness to comply with study-required follow-up and examinations.
- Prior history of other hematopoietic stem cell transplantation.
- History of ex vivo T-cell-depleted stem cell transplantation.
- Survival duration of less than 1 month after transplantation.
- Severe organ dysfunction, including significant impairment of hepatic, renal, cardiac, or pulmonary function.
- Active severe infection, such as uncontrolled pneumonia, sepsis, or other systemic infections.
- History of severe hypersensitivity reactions to study medications, including cyclophosphamide or anti-thymocyte globulin (ATG).
- Presence of severe psychiatric disorders or cognitive impairment that precludes compliance with study treatment and follow-up.
- Pregnant or lactating women.
- Concurrent malignancy of other organ system.
- Any other medical conditions deemed inappropriate for study participation by the treating investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Chengdu, Sichuan, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Chengdu, Sichuan, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.