drugset / Trial / NCT03384225
CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML
Phase 3
Unknown
120 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Changhai Hospital · collabChengdu PLA General Hospital · collabFujian Medical University Union Hospital · collabTang-Du Hospital · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabXiangya Hospital of Central South University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2016-08-01
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Publications
- Background Holowiecki J, Grosicki S, Robak T, Kyrcz-Krzemien S, Giebel S, Hellmann A, Skotnicki A, Jedrzejczak WW, Konopka L, Kuliczkowski K, Zdziarska B, Dmoszynska A, Marianska B, Pluta A, Zawilska K, Komarnicki M, Kloczko J, Sulek K, Haus O, Stella-Holowiecka B, Baran W, Jakubas B, Paluszewska M, Wierzbowska A, Kielbinski M, Jagoda K; Polish Adult Leukemia Group (PALG). Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study. Leukemia. 2004 May;18(5):989-97. doi: 10.1038/sj.leu.2403336.
- Background Holowiecki J, Grosicki S, Giebel S, Robak T, Kyrcz-Krzemien S, Kuliczkowski K, Skotnicki AB, Hellmann A, Sulek K, Dmoszynska A, Kloczko J, Jedrzejczak WW, Zdziarska B, Warzocha K, Zawilska K, Komarnicki M, Kielbinski M, Piatkowska-Jakubas B, Wierzbowska A, Wach M, Haus O. Cladribine, but not fludarabine, added to daunorubicin and cytarabine during induction prolongs survival of patients with acute myeloid leukemia: a multicenter, randomized phase III study. J Clin Oncol. 2012 Jul 10;30(20):2441-8. doi: 10.1200/JCO.2011.37.1286. Epub 2012 Apr 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 5 mg/m2 | — |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | — |