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

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborators: 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
• Treatments: 6-Mercaptopurine; BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Epirubicin; Mercaptopurine; Methotrexate

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