Leukemia
Conditions
Keywords
allogeneic peripheral blood stem cell transplantation, conditioning regimen, acute leukemia, relapsed/refractory
Brief summary
The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem cell transplantation.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-SCT) is the only way to cure relapsed/refractory acute leukemia. Busulfan/Cyclophosphamide (BuCy, Cytarabine, Busulfan, Cyclophosphamide) has been a classical conditioning regimen for allo-SCT. Substitution of Cyclophosphamide in the BuCy regimen with Fludarabine (BuF) resulted in reduced toxicity and similar efficacy. FLAG (fludarabine, cytarabine and granulocyte colony-stimulating factor) is a chemotherapy regimen that has been proved to be effective for relapsed/refractory acute leukemia as salvage therapy. To reduce the relapse and improve the survival of those patients with relapsed/refractory acute leukemia who receive allo-SCT, the novel conditioning regimen consisting of Busulfan/FLAG was developed. The combination of Bu and FLAG without interval shortens the duration of conditioning and the pneutropenic period of the patient compared with successive administration of FLAG followed with BuF. In addition, regarding the established safety and efficacy of BuF and FLAG, it is reasonable to expect similar safety and enhanced antileukemic efficacy for Bu/FLAG compared with BuF. In this study, the safety and efficacy of this regimen in patients with relapsed/refractory acute leukemia undergoing allogeneic peripheral blood stem cell transplantation was investigated.
Interventions
DRUGBusulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)
busulfan (3.2 mg/kg/day intravenously \[i.v.\], days -10 to -8)
DRUGCytarabine(Actavis Italy S.p.A)
cytarabine (1.6 g/m2/day, days -7 to -3)
DRUGFludarabine (Bayer)
fludarabine (30 mg/m2, day -7 to -3),
DRUGgranulocyte colony-stimulating factor (KirinKunpeng)
granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)
DRUGrabbit ATG（Sanofi/Genzyme）
ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2
Sponsors
309th Hospital of Chinese People's Liberation Army
Beijing Naval General Hospital
Space Center Hospital, Peking University
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* relapsed/refractory acute leukemia regardless of cytogenetics * All patients should aged 12 to 65 years * Have matched sibling donors, ≥8/10 HLA(human leukocyte antigen) matched unrelated donors or haploidentical donors * Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases
Exclusion criteria
* Patients aged less than 12 years old * Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases * Acute myeloid leukemia patients with t (15;17)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria | two years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Complete Remission as assessed by NCCN (National Comprehensive Cancer Network )criteria | 30 days |
| DFS(disease-free survival ) | two years |
| TRM(treatment-related mortality ) | two years |
| Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | three months |
| Number of participants with Regimen-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | 30 days |
Contacts
Primary ContactDaihong Liu, Doctor
Backup ContactLiping Dou, Doctor
Outcome results
None listed