For acute leukemia patients with early relapse after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell support from the original donor.
For acute leukemia patients experienced relapse 6 months or less after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we design a treatment protocol aiming to achieve complete remission for this high-risk group of patients with chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone (10mg/m2)for 5 days followed by infusion of mobilized peripheral stem cell from the original donor. For patients who failed to achieved remission,a second cycles will be given. For patients who achieved remission, the post-remission therapy is open depend on patient's intent: consolidation with one more cycle, second allo-HSCT with different donor or continuous DLI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
Rui Jin Hospital, Department of Hematology
Shanghai, China
complete remission (Bone marrow)
bone marrow aspiration performed on D30 after treatment. In case of less 5% blast with fully recovery of peripheral blood count is considered as CR. In case of less than 5% blast without fully recovered CBC is considered as CRi
Time frame: 30 days after treatment
chimerism (bone marrow)
chiremism analysis of patients bone marrow mononucleared cells at day 30 after treatment
Time frame: 30 days after treatment
survival
patients remain alive 6 months after enrollment
Time frame: 6 months
relapse (bone marrow)
bone marrow relapse within 6 months after treatment
Time frame: 6 months
non-relapse mortality
patients died due to any treatment complication or other cause except for disease progression or relapse
Time frame: 6 months
GVHD (clinical evaluation and grading)
grade II-IV acute GVHD and cGVHD if presented
Time frame: 6 months
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