Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042690
• Other study ID #: ALL-13
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in first phase of complete remission (CR1)

Description:

Although the high complete remission rate (80%-90%) can be achieved, the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemia(ALL) is only 25%-55% when they receive chemotherapy alone. The survival rate can be further improved uo to 50%-75% when they receive HLA-matched HSCT However, the chance of finding a HLA-matched donor is low, especially in China. Alternative donor such as halpo-identical related donor might be an choice.

Our retrospective analysis showed about 59% overall survival could be achieved when standard-risk adult ALL patients received halpo-identical HSCT.Therefore, we start this randomization controlled trial to compare the efficacy of haplo-identical HSCT with chemotherapy for adult(age:18-39 years old) ALL patients in CR1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• acute lymphoblastic leukemia

• 18-39 years old

• in first complete remission -Adequate hepatic function defined as: total bilirubin =2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) =2.5 times the institutional ULN -

• Adequate renal function defined as creatinine =3 times the institutional ULN

• No uncontrollable infection

• Performance Status(PS)score 0-2(WHO)

• Subjects able to provide written informed consent

Exclusion Criteria:

• having HLA-matched donor

• high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype(=5 chromosome abnormalities)(5)high white blood cell (WBC) count (B-ALL=30×109/L;T-ALL =100×109/L).

• pregnancy

• Loss of ability to freely provide consent due to psychiatric or physical illness

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• Haplo-identical HSCT
Haplo-identical Protocol: myeloablative human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) using pretransplant ATG and granulocyte colony-stimulating factor (G-CSF)-stimulated grafts (ATG+G-CSF) GVHD prevention regimen: CSA/MMF/MTX, CSA 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HRD-HSC and then gradually tapered. Every 12h, 0.5g MMF(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. MTX was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.

Drug:
• Chemotherapy
Patients receive 6 cycles of consolidation chemotherapy after randomization, including Hyper-CVAD-B regimen-Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen.Maintenance treatment includes MTX 20mg/m2/w,po,6-mercaptopurine 60 mg/m2/d,po,d1-d28,VP(VDS 4mg,d1, Prednisone 1mg/kg d1-7) every one month for 2 years.

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing
China	General Hospital of PLA	Beijing
China	Peking Union Hospital	Beijing
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (6)

Lead Sponsor	Collaborator
Peking University	Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University Aerospace Centre Hospital, The First Affiliated Hospital of Soochow University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		At 2 years from study entry
Secondary	Rate of cumulative incidence of relapse		At 2 years from study entry
Secondary	Overall survival (OS) rate		At 2 years from study entry
Secondary	nonrelapse mortality		At 2 years from study entry