Comparing two types of stem cell transplants for treating T-ALL
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
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 |
| Enrollment | 146 (estimated) |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06381817 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with acute T cell lymphoblastic leukemia who have a suitable haploidentical donor and meet specific health criteria.
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.
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 performed: While this approach is innovative, similar studies have shown promise in using cord blood in transplantation, suggesting potential for success.
Eligibility criteria
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 this trial is running
Suzhou, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.