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
Overview
- Phase
- Phase 1
- Intervention
- CLAM+PBSC
- Conditions
- Leukemia
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- complete remission (Bone marrow)
- Status
- Suspended
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jiong HU
Head, Blood and Marrow Transplantation Program, Chief Physician
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
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
Arms & Interventions
CLAM|PBSC
CLAM chemotherapy with mobilized PBSC infusion: Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
Intervention: CLAM+PBSC
Outcomes
Primary Outcomes
complete remission (Bone marrow)
Time Frame: 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 Outcomes
- survival(6 months)
- GVHD (clinical evaluation and grading)(6 months)
- chimerism (bone marrow)(30 days after treatment)
- relapse (bone marrow)(6 months)
- non-relapse mortality(6 months)