A Phase 3 interventional study of Chidamide and Cladribine in Lymphoma, Large B-Cell, Diffuse and Lymphoma, T-Cell, sponsored by Sichuan University. Recruiting at 11 sites in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Sichuan University · Phase 3, Interventional, and Treatment
High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 306 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.
Drug: Chidamide · Drug: Cladribine · Drug: Gemcitabine · Drug: Busulfan · Procedure: Autologous hematopoietic stem cell transplant
Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
Drug: Carmustine · Drug: Etoposide · Drug: Cytarabine · Drug: Melphalan · Procedure: Autologous hematopoietic stem cell transplant
30 mg oral twice weekly for 2 weeks
6 mg/m2 intravenously once daily @ Day -7 \~ -3
2500 mg/m2 intravenously @ Day -7, -3
3.2 mg/kg intravenously once daily @ Day -7 \~ -4
300 mg/m2 intravenously @ Day -8
200 mg/m2 intravenously once daily @ Day -7 \~ -4
400 mg/m2 intravenously once daily @ Day -7 \~ -4
140 mg/m2 intravenously @ Day -3
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Time frame: 2 years
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Time frame: 2 years
100 day adverse events (AE)
non-hematologic adverse events @ Day +100
Time frame: 100 days from transplant
100 day complete response (CR) rate
Complete response @ Day +100
Time frame: 100 days from transplant
Plan to share: Yes — Release after the publication of results of this trial
Supporting information: Study protocol
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Sichuan University