Last reviewed · How we verify
NCT06111612
Intensive Conditioning withTHI/Bu/Flu/Ara-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement
trial in Acute Myeloid Leukemia in 50 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 20 January 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2027 |
| Sites | 1 location across China |
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Myelodysplastic Neoplasm — all drugs for Myelodysplastic Neoplasm →
- Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
- Myeloid Sarcoma — all drugs for Myeloid Sarcoma →
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 55, any sex, with Acute Myeloid Leukemia or Myelodysplastic Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d from d -9 to d -8 (2 days), fludarabine at 30mg/m2/d from d -7 to d -3 (5 days), cytarabine at 1-1.5g/m2/d from d -7 to d -3 (5 days), and busulfan at 3.2mg/kg/d from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06111612
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukemia
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
- NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
- NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
- NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting
Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
- NCT06667466 — New Laser and Suction Sheath for Kidney Stone Treatment · not yet recruiting
- NCT07043374 — Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway · not yet recruiting
- NCT07415226 — Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes · not yet recruiting
- NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML · Phase 3 · not yet recruiting
- NCT07439120 — Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors · EARLY_PHASE1 · 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 NCT06111612 (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 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 22 July 2024
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/NCT06111612.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing