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Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.
Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLu-Bu-Cy | Experimental | Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLu-Bu-Cy | Drug | Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5. |
| Measure | Description | Time Frame |
|---|---|---|
| acute graft versus host disease (GVHD) | d100 incidence of acute GVHD, grade II-IV or grade III-IV | day 100 |
| chronic GVHD | 3-year incidence of chronic GVHD and extensive cGVHD | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| non-relapse mortality (NRM) | estimated 3-year NRM after transplantation (death not due to relapse disease) | 3 years |
| cumulated incidence of relapse (CIR) | estimated 3-year CIR after transplantation |
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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 |
|---|---|---|---|---|---|---|
| Blood and Marrow Transplantation Center, Rui Jin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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|
| 3 years |
| event-free survival (EFS) | estimated 3-year EFS estimated 3-year EFS after transplantation | 3 years |
| overall survival (OS) | estimated 3-year OS after transplantation | 3 years |
| GVHD-free, relapse-free survival (GRFS) | estimated 3-year survival for patients without relapse, without III-IV aGVHD and without cGVHD required systemic treatment | 3 years |