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NCT03384225
CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML
Phase 3 trial testing Cladribine in High Risk Acute Myeloid Leukemia in 120 participants. Status unknown.
31 July 2022
Quick facts
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 August 2016 |
| Primary completion | 31 July 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cladribine (CLADRIBINE) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Busulfan — full drug profile →
- Cytarabine — full drug profile →
Conditions studied
- High Risk Acute Myeloid Leukemia — all drugs for High Risk Acute Myeloid Leukemia →
- Allogeneic Hematopoeitic Stem Cell Transplantation — all drugs for Allogeneic Hematopoeitic Stem Cell Transplantation →
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 50, any sex, with High Risk Acute Myeloid Leukemia or Allogeneic Hematopoeitic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after haploidentical allogeneic HSCT in high risk and refractory AML patients as compared with fludarabine based conditioning regimen(FBA). Study design: open-labed, prospective, multicenter, randomized control study Number of subjects: 60 each group Treatment: CBA group: CBA as HSCT conditioning which including cladribine 5mg/m2 day -6 to day -2 , busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2. FBA group: FBA as HSCT conditioning which including fludarabine 30mg/m2 day -6 to day -2, busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Haploidentical Stem Cell Transplantation for Acute Myeloid Leukemia: Current Therapies, Challenges and Future Prospective.
Chang YJ, Zhao XY, Huang XJ. · · 2021 · cited 15× · PMID 34778077 · DOI 10.3389/fonc.2021.758512
Verify or expand the search:
- PubMed search for NCT03384225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cladribine
Trials testing the same drug.
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- NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT06474663 — A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabi · Phase 1 · withdrawn
- NCT06504459 — Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment · Phase 2 · recruiting
- NCT06561360 — A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) · Phase 2 · recruiting
Other recruiting trials for High Risk Acute Myeloid Leukemia
Currently open trials in the same condition.
- NCT06472128 — Novel Digital Application for Patients With Acute Leukemia · NA · recruiting
- NCT06394011 — Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients · Phase 2 · recruiting
- NCT02861417 — Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing · Phase 2 · active not 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 NCT03384225 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 12 October 2021
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/NCT03384225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing