CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study

Conditions
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Leukemia

Intervention / Treatment
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* Drug: CLAM+PBSC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLAM|PBSC<br>CLAM chemotherapy with mobilized PBSC infusion: Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5 | Drug: CLAM+PBSC<br>* Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5<br>* Other names: CLAMP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |