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Not yet recruitingNCT05681403Updated Jan 12, 2023

Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma

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

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Lymphoma
  • Autologous Hematopoietic Stem Cell Transplantation

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03

In context

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 →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • Meet the following requirements: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal value (ULN), total bilirubin (TBIL) ≤1.5×ULN (AST and ALT≤5×ULN are allowed if liver invasion occurs); serum creatinine ≤1.5×ULN; international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN; ECG examination was normal or abnormal without clinical significance, cardiac ultrasound showed left ventricular ejection fraction (LVEF) greater than 60, or CK-MB is normal, pro-BNP less than 900 pg/mL.
  • Female subjects have negative serum pregnancy test result. Subjects use highly effective birth control methods throughout the trial.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Active hepatitis B and C infection (positive HBV sAg and HBV-DNA more than 1x10\^3 copies/mL; HCV-RNA more than 1x10\^3 copies/mL) .
  • Positive HIV antibody.
  • Previous or current co-occurrence of other malignancies (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past 5 years) .
  • Primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment.
  • Pregnant or lactating female subjects and those who do not want to take contraceptive measures.
  • Drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or drug dependence (sedative hypnotics, analgesics, anesthetics, excitants and psychotropic drugs, etc.).
  • A history of mental disease or cognitive impairment.
  • Other conditions that the investigator determined are not suitable for participation in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    Improved BEAM regimen

    The enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT.

    Drug: Improved BEAM regimen

Interventions

  • DrugImproved 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

06

What researchers measure

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.

  5. 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.

07

Study locations

1 site
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    • Pengcheng He, MD · Contact · hepc@163.com · 0086-029-85324035
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05681403
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jan 12, 2023
Start date
Jan 15, 2023 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 12, 2023

Study contacts

Pengcheng He, MD
Contact
hepc@163.com
0086-029-85324035
Xiaoyan Zheng, MD
Contact
xiaoy_2008@126.com
0086-15829370502
Pengcheng He, MD
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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