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Modified BEAM Regimen for T Cell Lymphoma Underwent ASCT

Primary Purpose

Autologous Stem Cell Transplantation, Conditioning

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified BEAM
BEAM
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 Autologous Stem Cell Transplantation

Eligibility Criteria

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

Inclusion Criteria: 1) Subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with follow-up 2) 18~60 years old (including upper and lower limits) 3) Patients who were pathologically diagnosed as T-cell lymphoma and planned to undergo autologous hematopoietic stem cell transplantation 4) ECOG score 0-1 5) Organ function level must meet the following requirements: Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤ 1.5 × ULN (AST, ALT ≤ 5 is allowed in case of liver invasion × ULN); Kidney: blood creatinine ≤ 1.5 × ULN; Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Normal cardiac function: normal or abnormal ECG, no clinical significance, left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 60, or myocardial zymogram CK-MB is normal, and pro BNP is less than 900 pg/ml 6) The serum pregnancy test results of female subjects with reproductive capacity must be negative before the first use of the test drug Exclusion Criteria: 1.The previous anti-tumor treatment history of the subject meets one of the following conditions: Those who have previously received mitoxantrone or mitoxantrone liposomes Have received doxorubicin or other anthracyclines before, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin for other anthracyclines) 2. Hypersensitivity to any study drug or its components 3. Uncontrollable systemic diseases (such as active infection, uncontrollable hypertension, diabetes, etc.) 4. Heart function and disease meet one of the following conditions: Long QTc syndrome or QTc interval>480 ms Complete left bundle branch block, grade II or III atrioventricular block Serious and uncontrolled arrhythmia requiring drug treatment American New York Heart Association rating ≥ III Cardiac ejection fraction (LVEF) is less than 60% A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormality within 6 months before recruitment. 5. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL, hepatitis C virus RNA exceeds 1x103 copies/mL) 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive) 7. Have had or are suffering from other malignant tumors at the same time (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled in the past five years) 8. Have primary or secondary CNS lymphoma or have a history of CNS lymphoma at the time of recruitment 9. Pregnant and lactating women and childbearing age patients unwilling to take contraceptive measures 10. Those who have a history of drug abuse (use of narcotic drugs or psychotropic drugs for non-medical purposes) or dependence on drugs (sedative hypnotics, analgesics, narcotics, stimulants, and psychotropic drugs, etc.) 11. History of mental illness or cognitive impairment 12. Other investigators judged that it was not suitable to participate in this study.

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

modified BEAM conditioning regimen

BEAM conditioning regimen

Arm Description

Mitoxantrone liposome 24 mg/m2,ivgtt,d-7;BCNU 300 mg/m2,ivgtt,d-6; Ara-C 200 mg/m2 q12h,ivgtt,d-5- -2; Vp16 200 mg/m2 ,ivgtt,d-5- -2;

BCNU 300 mg/m2,-7d; Vp16 200 mg/m2,-6~-3d; Ara-C 100mg/m2 q12h,-6~-3d; Mel 140mg/m2,-2d

Outcomes

Primary Outcome Measures

relapse rate of T cell lymphoma
relapse rate at three years after transplantation

Secondary Outcome Measures

AEs
adverse reactions included gastrointestinal,liver,renal,heart toxicities
immune reconstruction
the recovery of T, B and NK cells
OS
overall survival
PFS
progression free survival

Full Information

First Posted
February 22, 2023
Last Updated
April 14, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05814718
Brief Title
Modified BEAM Regimen for T Cell Lymphoma Underwent ASCT
Official Title
Multicenter Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Carmustine, Etoposide and Cytarabine (Modified BEAM Protocol) for T Cell Lymphoma Underwent Autologous Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (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
A multicenter randomized study on the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with carmustine, etoposide, and cytarabine (modified BEAM protocol) in the pretreatment of T-cell lymphoma underwent autologous stem cell transplantation
Detailed Description
T-cell lymphoma patients with the indication of autologous stem cell transplantation will be divided into two groups,the control group will use BEAM as conditioning regimen and the experiment group will use modified BEAM regimen(included mitoxantrone liposome,then to compare the efficacy and safety of the two conditioning regimens for patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified BEAM conditioning regimen
Arm Type
Experimental
Arm Description
Mitoxantrone liposome 24 mg/m2,ivgtt,d-7;BCNU 300 mg/m2,ivgtt,d-6; Ara-C 200 mg/m2 q12h,ivgtt,d-5- -2; Vp16 200 mg/m2 ,ivgtt,d-5- -2;
Arm Title
BEAM conditioning regimen
Arm Type
Active Comparator
Arm Description
BCNU 300 mg/m2,-7d; Vp16 200 mg/m2,-6~-3d; Ara-C 100mg/m2 q12h,-6~-3d; Mel 140mg/m2,-2d
Intervention Type
Drug
Intervention Name(s)
modified BEAM
Other Intervention Name(s)
Mitoxantrone liposome, Carmustine, Cytarabine, Etoposide
Intervention Description
Mitoxantrone liposome 24 mg/m2,ivgtt,d-7;BCNU 300 mg/m2,ivgtt,d-6; Ara-C 200 mg/m2 q12h,ivgtt,d-5- -2; Vp16 200 mg/m2 ,ivgtt,d-5- -2;
Intervention Type
Drug
Intervention Name(s)
BEAM
Other Intervention Name(s)
Carmustine, Cytarabine, Etoposide, Melphalan
Intervention Description
BCNU 300 mg/m2,-7d; Vp16 200 mg/m2,-6~-3d; Ara-C 100mg/m2 q12h,-6~-3d; Mel 140mg/m2,-2d
Primary Outcome Measure Information:
Title
relapse rate of T cell lymphoma
Description
relapse rate at three years after transplantation
Time Frame
three years after transplantation
Secondary Outcome Measure Information:
Title
AEs
Description
adverse reactions included gastrointestinal,liver,renal,heart toxicities
Time Frame
from beginning of the conditioning to one month after conditioning
Title
immune reconstruction
Description
the recovery of T, B and NK cells
Time Frame
At 6 months post-transplantation
Title
OS
Description
overall survival
Time Frame
From date of diagnosis 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 HSCT until the end of follow-up or the date of disease relapse 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: 1) Subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with follow-up 2) 18~60 years old (including upper and lower limits) 3) Patients who were pathologically diagnosed as T-cell lymphoma and planned to undergo autologous hematopoietic stem cell transplantation 4) ECOG score 0-1 5) Organ function level must meet the following requirements: Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤ 1.5 × ULN (AST, ALT ≤ 5 is allowed in case of liver invasion × ULN); Kidney: blood creatinine ≤ 1.5 × ULN; Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Normal cardiac function: normal or abnormal ECG, no clinical significance, left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 60, or myocardial zymogram CK-MB is normal, and pro BNP is less than 900 pg/ml 6) The serum pregnancy test results of female subjects with reproductive capacity must be negative before the first use of the test drug Exclusion Criteria: 1.The previous anti-tumor treatment history of the subject meets one of the following conditions: Those who have previously received mitoxantrone or mitoxantrone liposomes Have received doxorubicin or other anthracyclines before, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin for other anthracyclines) 2. Hypersensitivity to any study drug or its components 3. Uncontrollable systemic diseases (such as active infection, uncontrollable hypertension, diabetes, etc.) 4. Heart function and disease meet one of the following conditions: Long QTc syndrome or QTc interval>480 ms Complete left bundle branch block, grade II or III atrioventricular block Serious and uncontrolled arrhythmia requiring drug treatment American New York Heart Association rating ≥ III Cardiac ejection fraction (LVEF) is less than 60% A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormality within 6 months before recruitment. 5. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL, hepatitis C virus RNA exceeds 1x103 copies/mL) 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive) 7. Have had or are suffering from other malignant tumors at the same time (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled in the past five years) 8. Have primary or secondary CNS lymphoma or have a history of CNS lymphoma at the time of recruitment 9. Pregnant and lactating women and childbearing age patients unwilling to take contraceptive measures 10. Those who have a history of drug abuse (use of narcotic drugs or psychotropic drugs for non-medical purposes) or dependence on drugs (sedative hypnotics, analgesics, narcotics, stimulants, and psychotropic drugs, etc.) 11. History of mental illness or cognitive impairment 12. Other investigators judged that it was not suitable to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoning Wang, M.D.
Phone
+8618991232608
Email
wangxn99@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiaonig wang, M.D.
Phone
+8618991232608
Email
wangxn99@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoning Wang
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Modified BEAM Regimen for T Cell Lymphoma Underwent ASCT

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