Clinical trial NCT02042690: Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients
Official title: Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
hematopoietic stem cell transplantation
chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Wuhan Union Hospital, China
name: Chinese PLA General Hospital
name: The First Affiliated Hospital of Soochow University
name: Peking University Aerospace Center Hospital
First posted: 2014-01-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After 1 year of enrollment, randomization was terminated because of the patients's intention to crossover between the two intervention groups (total enrolled n=16). The sample size was recalculated in July 2015, and the ethics committee agreed to modify the randomization scheme to intention-to-therapy (ITT). Patients who met the recruitment criteria after the second consolidation participated fully in discussions with their doctors and then made decisions on their own regarding their intention to receive haplo-SCT. For each patient, informed consent was obtained from that patient or his/her guardian in accordance with the Declaration of Helsinki.
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: At 2 years from study entry
Secondary outcomes:
measure: Rate of cumulative incidence of relapse
timeFrame: At 2 years from study entry
measure: Overall survival (OS) rate
timeFrame: At 2 years from study entry
measure: nonrelapse mortality
timeFrame: At 2 years from study entry
Other outcomes:
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Beijing
country: China
facility: General Hospital of PLA
city: Beijing
country: China
facility: Peking Union Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-Jun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lv M, Jiang Q, Zhou DB, Hu Y, Liu DH, Wu DP, Wang JB, Jiang H, Wang J, Chang YJ, Wang Y, Zhang XH, Xu LP, Liu KY, Huang XJ. Comparison of haplo-SCT and chemotherapy for young adults with standard-risk Ph-negative acute lymphoblastic leukemia in CR1. J Hematol Oncol. 2020 May 15;13(1):52. doi: 10.1186/s13045-020-00879-1.