NCT06381817RecruitingPhase 3
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
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
Source: ClinicalTrials.gov · Last updated 26 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are: Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL. Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- NCT number
- NCT06381817
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 146
- From 1 Apr 2024 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
Other illness
- With other malignancies
- With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
- With any conditions not suitable for the trial (investigators' decision)
Other
- Failing to acquire a suitable unrelated cord blood unit
- With severe organ dysfunction
- In pregnancy or lactation period
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.