Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute T Cell Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Cord Blood | — | UNRESOLVED | — |
| Haploidentical Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haplo-cord HCT | Biological | — | UNRESOLVED |
| Haplo-HCT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Haplo-cord HCT
- description
- Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation
- interventionNames
- Biological: Haplo-cord HCT
- type
- ACTIVE_COMPARATOR
- label
- Haplo-HCT
- description
- Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation
- interventionNames
- Biological: Haplo-HCT
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available