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Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma

Primary Purpose

Lymphoma, Autologous Hematopoietic Stem Cell Transplantation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Improved BEAM regimen
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Improved BEAM regimen

Arm Description

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

Outcomes

Primary Outcome Measures

recurrence rate
The rate of lymphoma relapse

Secondary Outcome Measures

AEs
adverse effects
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 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.
OS
Overall survival
PFS
Progression free survival

Full Information

First Posted
December 11, 2022
Last Updated
December 26, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05681403
Brief Title
Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma
Official Title
Clinical Study of Mitoxantrone Hydrochloride Liposome, Carmostine, Etoposide and Cytarabine as Conditioning Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Autologous Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Improved BEAM regimen
Arm Type
Experimental
Arm Description
The enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT.
Intervention Type
Drug
Intervention Name(s)
Improved BEAM regimen
Other Intervention Name(s)
Conditioning treatment with improved BEAM regimen
Intervention Description
Mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients.
Primary Outcome Measure Information:
Title
recurrence rate
Description
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 Outcome Measure Information:
Title
AEs
Description
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.
Title
Time of neutrophil implantation
Description
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.
Title
Time of platelet implantation
Description
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.
Title
OS
Description
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.
Title
PFS
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pengcheng He, MD
Phone
0086-029-85324035
Email
hepc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Zheng, MD
Phone
0086-15829370502
Email
xiaoy_2008@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pengcheng He, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengcheng He, MD
Phone
0086-029-85324035
Email
hepc@163.com

12. IPD Sharing Statement

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Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma

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