Modified BEAM Regimen for T Cell Lymphoma Underwent ASCT

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05814718

Collaborator

(none)

122

Enrollment

Location

Arms

32.6

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Autologous Stem Cell Transplantation Conditioning	Drug: modified BEAM Drug: BEAM	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: modified BEAM conditioning regimen 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；	Drug: modified BEAM 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； Other Names: Mitoxantrone liposome Carmustine Cytarabine Etoposide
Active Comparator: BEAM conditioning regimen BCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d	Drug: BEAM BCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d Other Names: Carmustine Cytarabine Etoposide Melphalan

Arm

Intervention/Treatment

Experimental: modified BEAM conditioning regimen

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；

Drug: modified BEAM

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；

Other Names:

Mitoxantrone liposome

Carmustine

Cytarabine

Etoposide

Active Comparator: BEAM conditioning regimen

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

Drug: BEAM

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

Other Names:

Carmustine

Cytarabine

Etoposide

Melphalan

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

AEs [from beginning of the conditioning to one month after conditioning]
adverse reactions included gastrointestinal,liver,renal,heart toxicities
immune reconstruction [At 6 months post-transplantation]
the recovery of T, B and NK cells
OS [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.]
overall survival
PFS [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.]
progression free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.
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.