Autologous Stem Cell TransplantationNCT05814718
Modified BEAM Regimen for T Cell Lymphoma Underwent ASCT
A study testing modified BEAM and BEAM in people with Autologous Stem Cell Transplantation and Conditioning, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autologous Stem Cell Transplantation, Conditioning
- What is being tested?
- modified BEAM and BEAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
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- Long QTc syndrome or QTc interval>480 ms
- Complete left bundle branch block, grade II or III atrioventricular block
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
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
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
Read the 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.
- Conditions
- Autologous Stem Cell Transplantation, Conditioning
- Being tested
- modified BEAM, BEAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified BEAMDrug
Also called Mitoxantrone liposome, Carmustine, Cytarabine, Etoposide
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；
BEAMDrug
Also called Carmustine, Cytarabine, Etoposide, Melphalan
BCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d
| Study group | Role | What they receive |
|---|---|---|
| modified BEAM conditioning regimen | Experimental | 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； Receives: Drug: modified BEAM |
| BEAM conditioning regimen | Active comparator | BCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d Receives: Drug: BEAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate of T cell lymphoma
relapse rate at three years after transplantation
Measured: three years after transplantation
Secondary outcomes (4)
AEs
adverse reactions included gastrointestinal,liver,renal,heart toxicities
Measured: from beginning of the conditioning to one month after conditioning
immune reconstruction
the recovery of T, B and NK cells
Measured: At 6 months post-transplantation
OS
overall survival
Measured: 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.
PFS
progression free survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Apr 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoning Wang, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814718
- Sponsor's protocol ID
- XJTU1AF2022LSL-018
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05814718
- Acronym / sponsor ID
- XJTU1AF2022LSL-018
- Conditions
- Autologous Stem Cell Transplantation, Conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified BEAM conditioning regimen | Experimental | Drug: modified BEAMMitoxantrone 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； |
| BEAM conditioning regimen | Active comparator | Drug: BEAMBCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (11 listed)
- 1.The previous anti-tumor treatment history of the subject meets one of the following conditions:
- <!-- -->
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified BEAMAlso: Mitoxantrone liposome, Carmustine, Cytarabine, EtoposideMitoxantrone 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 conditioning regimen |
| BEAMAlso: Carmustine, Cytarabine, Etoposide, MelphalanBCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d | Drug | BEAM conditioning regimen |
Primary outcome
relapse rate of T cell lymphoma
Time frame: three years after transplantation
relapse rate at three years after transplantation
4 secondary outcomes
AEs
Time frame: from beginning of the conditioning to one month after conditioning
immune reconstruction
Time frame: At 6 months post-transplantation
OS
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.
PFS
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoning Wang principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified BEAM and BEAM in people with Autologous Stem Cell Transplantation and Conditioning, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoning Wang, M.D. (+8618991232608, wangxn99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate of T cell lymphoma (time frame: three years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 4 Nov 2026.