Clinical trial NCT02784561: Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation
Official title: Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leukemia
Keywords: allogeneic peripheral blood stem cell transplantation
conditioning regimen
acute leukemia
relapsed/refractory
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: 309th Hospital of Chinese People's Liberation Army
name: Beijing Naval General Hospital
name: Space Center Hospital, Peking University
First posted: 2016-05-27
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria
timeFrame: two years
Secondary outcomes:
measure: Rate of Complete Remission as assessed by NCCN (National Comprehensive Cancer Network )criteria
timeFrame: 30 days
measure: DFS(disease-free survival )
timeFrame: two years
measure: TRM(treatment-related mortality )
timeFrame: two years
measure: Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
timeFrame: three months
measure: 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
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu, Doctor
role: STUDY_DIRECTOR
References:
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