Comparing two types of stem cell transplants for treating T-ALL
Official title: Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial
Run by The First Affiliated Hospital of Soochow University · NCT06381817 · Data updated 2026-11-12
This study is testing if a new type of stem cell transplant that uses both a family donor and cord blood can help people with acute T cell leukemia do better than the standard transplant method.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | April 26, 2024 |
| Trial ID | NCT06381817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with acute T cell lymphoblastic leukemia who have a suitable haploidentical donor and meet specific health criteria.
✕Probably not a fit
Patients with other malignancies, severe organ dysfunction, or those who have previously undergone certain types of stem cell therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine the effectiveness and safety of haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) in treating acute T cell lymphoblastic leukemia (T-ALL). The study will compare haplo-cord HCT to traditional haploidentical transplantation (haplo-HCT) to assess whether the addition of cord blood reduces relapse rates and identifies any associated medical problems. Participants will receive both the haploidentical graft and the cord blood unit on the same day. The trial will include patients with specific eligibility criteria, including those with measurable residual disease.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce relapse rates for patients with T-ALL.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in using cord blood in transplantation, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with acute T cell lymphoblastic leukemia * With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction * Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor * With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Signing an informed consent form, having the ability to comply with study and follow-up procedures Exclusion Criteria: * With other malignancies * Failing to acquire a suitable unrelated cord blood unit * With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy * With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation * With severe organ dysfunction * In pregnancy or lactation period * With any conditions not suitable for the trial (investigators' decision)
Where it's running
-
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Yang XU — The First Affiliated Hospital of Soochow University
- Study coordinator: Yang XU
- Email: xuyang1020@126.com
- Phone: 86+051267781850
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Amnioinfusion to Protect Newborns After Meconium in Amniotic Fluid
This trial tests whether a structured lactated Ringer's amnioinfusion during labor can reduce breathing problems and related complications in babies whose amniotic fluid contains meconium.
-
Cord blood platelet-rich plasma plus penile traction versus traction alone for Peyronie's disease
This tests whether adding cord blood platelet-rich plasma injections to penile traction helps men with Peyronie's disease and significant penile curvature.
-
Comparing two types of stem cell transplants for children
This study is testing whether a new type of stem cell transplant can reduce complications and improve life for children who need this treatment.
-
New treatment to improve cord blood engraftment in children with leukemia after transplant
This study is testing a new treatment to see if it can help children with leukemia have better success with cord blood transplants after their treatment.
-
Haploidentical stem cell transplantation with early ATG and low-dose cyclophosphamide
This study is testing if giving a special medication and a lower dose of chemotherapy right after a stem cell transplant can help patients who don't have a matched donor recover better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.