Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Haplo-identical HSCT; Chemotherapy
Intervention type(s): Procedure; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Methotrexate; arabinoside; cyclophosphamide; Epirubicin; dexamethasone; 6-mercaptopurine; Vindesin; Predisone
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Methotrexate; Epirubicin; Mercaptopurine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; hematopoietic stem cell transplantation; chemotherapy