High Risk Acute Myeloid Leukemia Clinical Trial
Official title:
CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of AML confirmed by bone marrow cell morphology, immunology, cytogenetics and molecular biology (MICM). Blast crisis of chronic myeloid leukemia (CML) and AML transferred from myelodysplastic syndrome(MDS) or other diseases are also included. 2. AML with high risk cytogenetic abnormals, such as FLT3- ITD, et al. 3. Patients fulfilled at least one of the following criteria defining refractory AML:(1) primary induction failure (PIF) after 2 or more cycles of chemotherapy; (2) first early relapse after a remission duration of fewer than 12 months and refractory to salvage combination chemotherapy; (3) second or subsequent relapse . 4. Have no HLA matched siblings or unrelated donors, but have haploidentical donor. The donor must match the health conditions of hematopoietic stem cell donation (criteria of China Marrow Donor Program) and be willing to donate. 5. Performance status score no more than 2 (ECOG criteria). 6. Adequate organ function as defined by the following criteria:ALT, AST and total serum bilirubin <2×ULN (upper limit of normal), Serum creatinine and BUN <1.25×ULN. 7. Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation. 8. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. 9. Willingness and ability to comly with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Presence of any condition inappropriate for HSCT. 2. Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure et al. 3. Have no suitable donor. 4. Pregnancy or breast feeding. 5. Current treatment on another clinical trail. 6. Any other condition the investigator judged the patient inappropriate for entry into this study |
Country | Name | City | State |
---|---|---|---|
China | Shanghai general hospital, Shanghai Jiaotong university school of medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Changhai Hospital, Chengdu PLA General Hospital, Fujian Medical University Union Hospital, Tang-Du Hospital, Tongji Hospital, Wuhan Union Hospital, China, Xiangya Hospital of Central South University |
China,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cumulative relapse rate at 2 year | The percentage of all patients who are relapsed within 2 years after allogeneic HSCT. | 2 years | |
Secondary | overall survival at 2 year | The percentage of all patients who are still alive 2 years after allogeneic HSCT. | 2 years | |
Secondary | disease free survival at 2year | The percentage of all patients who are leukemia free 2 years after allogeneic HSCT. | 2 years | |
Secondary | non-relapse mortality at 2year | The percentage of patients who are dead within 2 years of all reasons except relapse. | 2 years | |
Secondary | non-relapse mortality at 100days | The percentage of patients who are dead within 100days of all reasons except relapse. | 100 days |
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