A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

Conditions

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma

Brief summary

A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.

Jinhua Ren, Xiaofeng Luo, Minmin Chen, Min Xiao, Qian Li et al. (10 authors)

Blood2019-11-13

10.1182/blood-2019-127595

G-CSF-primed haplo-identical HSCT with intensive immunosuppressive and myelosuppressive treatments does not increase the risk of pre-engraftment bloodstream infection: a multicenter case-control study.

Ren J, Lin Q, Chen W, Lin C, Zhang Y, Chen C, Chen S, Yuan X, Chen P, Luo X, Lin Y, Shen L, Guo M, Chen Q, Xiao M, Chen Y, Wu X, Zeng Y, Chen Z, Ma X, Hu J, Yang T.

2019-01-263 citations

10.1007/s10096-019-03482-6

Challenging the Prognostic Value of MRD: Sequential Tumor-Ablative Conditioning of FA5-Bucy for Ph-Positive Acute Lymphoblastic Leukemia

Jianda Hu, Min Xiao, Jinhua Ren, Xiaozhu Yang, Yuxin Zhang et al. (9 authors)

Blood2017-12-07

10.1182/blood.v130.suppl_1.2052.2052

A 5-Day Cytoreductive Chemotherapy Followed By Haplo-Identical HSCT (FA5-Bucy) As a Tumor-Ablative Regimen Improved the Survival of Patients with Advanced Hematological Malignancies

Ting Yang, Jinhua Ren, Qiaoxian Lin, Xiaohong Yuan, Xiaofeng Luo et al. (9 authors)

Blood2016-12-02

10.1182/blood.v128.22.4674.4674

Intensive Chemotherapy with DA-Edoch Followed By Allogeneic Hematopoietic Stem Cell Transplantation Improved the Outcome in HTLV-1 Associated Adult T Cell Leukemia (ATL)

Jianda Hu, Ting Yang, Zhengjun Wu, Jinghua Ren, Xiaoyun Zheng et al. (7 authors)

Blood2016-12-02

10.1182/blood.v128.22.5840.5840

Interventions

DRUGFludarabine and Cytarabine followed by IV busulfan and cyclophosphamide

Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Signed written informed consent * Aged between 0-65 years * Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1 * Patients with advanced MDS * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70%

Exclusion criteria

* Pregnant or lactating females * Current participation in another clinical trial * Contra-indication to one of the drug of the regimen * Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen

Design outcomes

Primary

Measure	Time frame
Relapse rate at one year after allo-SCT	one year

Secondary

Measure	Time frame	Description
Even free survival	two year	* Overall Survival * Leukemia Free Survival * Graft Versus Host Disease * Regimen related toxicity

Countries

China

Contacts

Primary ContactTing Yang, Prof.

yang.hopeting@gmail.com+86-591-83357896

Backup ContactJianda Hu, Prof.

jdhu@medmail.com.cn+86-591-83357896

Outcome results

None listed