An interventional study of Improved BEAM regimen in Lymphoma and Autologous Hematopoietic Stem Cell Transplantation, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
This is a single arm, open, single-center clinical study. The patients who are diagnosed with lymphoma and intend to undergo ASCT will be enrolled. The aim of this study is to investigate the efficacy and safety of the conditioning regimen using mitoxantrone hydrochloride liposome, BCNU, etoposide and cytarabine for ASCT.
High-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT) is considered the standard of care for patients with chemotherapy-sensitive relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL). BEAM regimen is the most commonly used conditioning regimen for ASCT in lymphoma. But its application is limited by the adverse drug reactions. This present project is a one-arm, open, single-center clinical study. It aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, carmostine, etoposide, and cytarabine as the conditioning regimen for ASCT in patients with lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 53 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
The enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT.
Drug: Improved BEAM regimen
Mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients.
Also known as: Conditioning treatment with improved BEAM regimen
recurrence rate
The rate of lymphoma relapse
Time frame: From date of treating with conditioning regimen until lymphoma relapse, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.
AEs
adverse effects
Time frame: From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months.
Time of neutrophil implantation
On the first day of three consecutive days, the peripheral blood neutrophil count (ANC) was ≥0.5×10\^9/L without blood transfusion.
Time frame: From date of the treatment with the conditioning regimen until the time of neutrophil implantation or date of death from any cause, whichever came first, assessed up to 36 months.
Time of platelet implantation
On the first day of three consecutive days, the peripheral blood platelet count (PLT) was ≥20×10\^9/L without blood transfusion.
Time frame: From date of the treatment with the conditioning regimen until the time of platelet implantation or date of death from any cause, whichever came first, assessed up to 36 months.
OS
Overall survival
Time frame: From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months.
PFS
Progression free survival
Time frame: From date of treating with conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, , assessed up to 36 months.
This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University