Leukemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCLAM+PBSC
Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with acute leukemia relapsed within 6 months after previous allo-HSCT * no active GVHD * mobilized PBSC from the original donor available
Exclusion criteria
* ECOG \>=3 * liver function/renal function damage (over 2 X upper normal range) * active infection including CMV and EBV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission (Bone marrow) | 30 days after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chimerism (bone marrow) | 30 days after treatment | chiremism analysis of patients bone marrow mononucleared cells at day 30 after treatment |
| survival | 6 months | patients remain alive 6 months after enrollment |
| relapse (bone marrow) | 6 months | bone marrow relapse within 6 months after treatment |
| non-relapse mortality | 6 months | patients died due to any treatment complication or other cause except for disease progression or relapse |
| GVHD (clinical evaluation and grading) | 6 months | grade II-IV acute GVHD and cGVHD if presented |
Countries
China
Outcome results
None listed