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The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. To further improve the outcome of transplantation patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib combined with Chidamide | Experimental | All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid [p.o.], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide | Drug | Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd; |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria | Defined as the proportion of participants whose underlying malignancy relapsed. | 365 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| DFS(disease-free survival ) | DFS was defined as survival with no evidence of relapse or progression. | 365 days after transplantation |
| TRM(treatment-related mortality ) | Defined as the proportion of subjects who died due to causes other than malignancy relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daihong Liu | Contact | 86-13681171597 | daihongrm@163.com | |
| Liping Dou | Contact | 96-13681207138 | lipingruirui@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Daihong Liu | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32107550 | Background | Ferrante F, Giaimo BD, Bartkuhn M, Zimmermann T, Close V, Mertens D, Nist A, Stiewe T, Meier-Soelch J, Kracht M, Just S, Kloble P, Oswald F, Borggrefe T. HDAC3 functions as a positive regulator in Notch signal transduction. Nucleic Acids Res. 2020 Apr 17;48(7):3496-3512. doi: 10.1093/nar/gkaa088. | |
| 25645356 | Background |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C540383 | ruxolitinib |
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| 365 days after transplantation |
| Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | Defined as the proportion of participants who developed acute GVHD. | 100 days after transplantation |
| Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) | Defined as the proportion of participants who developed chronic GVHD. | 365 days after transplantation |
| OS(overall survival ) | OS was defined as the time from transplantation to death due to any cause. | 365 days after transplantation |
| Failure-free survival (FFS) | Defined as the time from transplantation to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). | 365 days after transplantation |
| infection rate | Defined as the proportion of participants who developed all kinds of infection. | 365 days after transplantation |
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| 22015773 | Background | Stumpel DJ, Schneider P, Seslija L, Osaki H, Williams O, Pieters R, Stam RW. Connectivity mapping identifies HDAC inhibitors for the treatment of t(4;11)-positive infant acute lymphoblastic leukemia. Leukemia. 2012 Apr;26(4):682-92. doi: 10.1038/leu.2011.278. Epub 2011 Oct 21. |
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