Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma

December 26, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

Clinical Study of Mitoxantrone Hydrochloride Liposome, Carmostine, Etoposide and Cytarabine as Conditioning Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Lymphoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pengcheng He, MD
  • Phone Number: 0086-029-85324035
  • Email: hepc@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
          • Pengcheng He, MD
          • Phone Number: 0086-029-85324035
          • Email: hepc@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients.
Other Names:
  • Conditioning treatment with improved BEAM regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
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.
The rate of lymphoma relapse
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs
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.
adverse effects
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
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.
On the first day of three consecutive days, the peripheral blood neutrophil count (ANC) was ≥0.5×10^9/L without blood transfusion.
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
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.
On the first day of three consecutive days, the peripheral blood platelet count (PLT) was ≥20×10^9/L without blood transfusion.
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
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.
Overall survival
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
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.
Progression free survival
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Pengcheng He, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSK-238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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