pediatric high-risk acute leukemia
Conditions
Interventions
Case series:To carry out allogeneic umbilical cord blood stem cell transplantation with CLAG + Bu/CY as conditioning regimen for the treatment of high-risk acute leukemia in children
Sponsors
Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age = 300 × 10^9/L acute lymphoblastic leukemia with MLL gene rearrangement; (2) Acute myeloid leukemia with monomer 7, monomer 5/5q- or complex karyotype; (3) Except for t(1; 11) and t(9; 11), other acute myeloid leukemia with 11q23/MLL gene rearrangement; (4) Acute myeloid leukemia with FLT3-ITD allele ratio AR >= 0.5 and without NPM1 mutation or other recurrent genetic abnormalities; (5) Acute myeloid leukemia with t(16; 21) (P11; q22) FUS/ERG, t(6; 9)(P22; q34) DEK/NUP214, t(7; 12) (q36; P13) MNX1/ETV6, inv3(q21; q26) / t(3; 3) (q21; q26) RPN1/MECOM, inv(16)(P13; q24) CBFA2T3/ GLIS2, t(5; 11)(q35; p15.5) NUP98/NSD1, t(11; 12)(p15; P13) NUP98/KDM5A, etc; (6) Refractory acute leukemia who received two standard induction chemotherapy courses without complete remission; (7) Early relapse or multiple relapses after complete remission of acute leukemia, including extramedullary relapse; 3. There is no suitable sibing-matched donor; 4. ECOG score <= 2 points; 5. Informed consent of the legal guardian and voluntary paticipation; Subjects suitable for this study should meet the above five criteria at the same time.
Exclusion criteria
Exclusion criteria: 1. Age > 18 years old; 2. Have serious organ dysfunction or diseases, such as heart, liver, kidney, pancreas and other serious diseases and dysfunction; 3. HIV positive, active hepatitis B / AIDS or active tuberculosis. 4. Suffering from other serious infections that are uncontrollable and may be life-threatening; 5. Suffering from other primary tumors; 6. Suffering from serious mental illness, which may interfere with the participation in this clinical study; 7. Hypersensitivity to blood products; 8. Previously received hematopoietic stem cell transplantation; 9. Any other circumstances recognized by the investigator that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Leukemia free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of GVHD;Transplant related mortality; | — |
Countries
China
Contacts
Public ContactZhu Xiaofan
Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed