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
Qualifiers
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
Treatments tested in this trial
- Improved BEAM regimen
Treatment groups
53 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov