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NCT06557161
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
Phase 2 trial testing TBI in Acute Lymphoblastic Leukemia, Adult in 170 participants. Currently enrolling.
31 August 2029
Quick facts
| Lead sponsor | The First Affiliated Hospital of Zhengzhou University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 1 March 2025 |
| Primary completion | 31 August 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- TBI — full drug profile →
- TMLI
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia, Adult — all drugs for Acute Lymphoblastic Leukemia, Adult →
Sponsor
The First Affiliated Hospital of Zhengzhou University
Who can join
Adults 18 to 65, any sex, with Acute Lymphoblastic Leukemia, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06557161
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Related trials
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Other recruiting trials for Acute Lymphoblastic Leukemia, Adult
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06557161 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Zhengzhou University
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06557161.
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