CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after HLA matched 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: 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
• Treatments: Busulfan; Cladribine; Cytarabine; Fludarabine

Criteria

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 HLA 9/10 or 10/10 matched siblings or unrelated 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.