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NCT05674539
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase 3 trial testing Fludarabine and Busulfan in Acute Myeloid Leukemia, Adult in 200 participants. Enrolling by invitation.
30 December 2025
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 15 February 2023 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fludarabine and Busulfan — full drug profile →
- Fludarabine and Melphalan — full drug profile →
Conditions studied
- Acute Myeloid Leukemia, Adult — all drugs for Acute Myeloid Leukemia, Adult →
- Myelodysplastic Syndrome(MDS) — all drugs for Myelodysplastic Syndrome(MDS) →
- Allogeneic Hematopoietic Stem Cell Transplantation — all drugs for Allogeneic Hematopoietic Stem Cell Transplantation →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
18 and older, any sex, with Acute Myeloid Leukemia, Adult or Myelodysplastic Syndrome(MDS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are: * The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. * The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05674539
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
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- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · not yet recruiting
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 NCT05674539 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 10 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/NCT05674539.
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