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Low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLAM|PBSC | Experimental | CLAM chemotherapy with mobilized PBSC infusion: Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLAM+PBSC | Drug | Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| chimerism (bone marrow) | chiremism analysis of patients bone marrow mononucleared cells at day 30 after treatment | 30 days after treatment |
| survival | patients remain alive 6 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiong HU, M.D., | Rui Jin Hospital, Shanghai JiaoTong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital, Department of Hematology | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 6 months |
| relapse (bone marrow) | bone marrow relapse within 6 months after treatment | 6 months |
| non-relapse mortality | patients died due to any treatment complication or other cause except for disease progression or relapse | 6 months |
| GVHD (clinical evaluation and grading) | grade II-IV acute GVHD and cGVHD if presented | 6 months |