Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Aged 18-60 years, male or female.
Subjects pathologically diagnosed non-Hodgkin's lymphoma, and intend to undergo autologous hematopoietic stem cell transplantation.
ECOG score 0-1.
Disqualifiers
Previous recipients of mitoxantrone or mitoxantrone liposome; previous treatment with doxorubicin or other anthracyclines, with a cumulative dose of doxorubicin > 360 mg/m2 (for other anthracyclines, 1 mg doxorubicin is equivalent to 2 mg epirubicin).
Hypersensitivity to any study drug or its component.
Uncontrolled systemic diseases (e.g., active infections, uncontrolled hypertension, diabetes, etc.) .
Cardiac function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interval >480 ms; b) Complete left bundle branch block, degree II or III atrioventricular block; c) Severe uncontrolled arrhythmias that require medical treatment; d) New York College of Cardiology Grade ≥ III; e) Cardiac ejection fraction (LVEF) less than 60%; f) A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
Trial design
Design model
Single group
Treatments tested in this trial
Improved BEAM regimen
DrugMitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients.
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: Improved BEAM regimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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