LymphomaNCT05681403
Clinical Study of Improved BEAM Conditioning Regimen for ASCT in Lymphoma
A study testing Improved BEAM regimen in people with Lymphoma and Autologous Hematopoietic Stem Cell Transplantation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, Autologous Hematopoietic Stem Cell Transplantation
- What is being tested?
- Improved BEAM regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, MD, 0086-029-85324035, hepc@163.com
About this study
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
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.
Read the 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.
- Being tested
- Improved BEAM regimen
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved BEAM regimenDrug
Also called Conditioning treatment with improved BEAM regimen
Mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients.
| Study group | Role | What they receive |
|---|---|---|
| Improved BEAM regimen | Experimental | The enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT. Receives: Drug: Improved BEAM regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
The rate of lymphoma relapse
Measured: 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 outcomes (5)
AEs
adverse effects
Measured: 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
On the first day of three consecutive days, the peripheral blood neutrophil count (ANC) was ≥0.5×10^9/L without blood transfusion.
Measured: 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
On the first day of three consecutive days, the peripheral blood platelet count (PLT) was ≥20×10^9/L without blood transfusion.
Measured: 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
Overall survival
Measured: 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
Progression free survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengcheng He, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681403
- Sponsor's protocol ID
- XJTU1AF2022LSK-238
- Status last verified
- Oct 2022
- First submitted
- 11 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05681403
- Acronym / sponsor ID
- XJTU1AF2022LSK-238
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improved BEAM regimen | Experimental | Drug: Improved BEAM regimenThe enrolled subjects will received mitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine as conditioning regimen for ASCT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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) .
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 |
|---|---|---|
| Improved BEAM regimenAlso: Conditioning treatment with improved BEAM regimenMitoxantrone hydrochloride liposome, carmostine, etoposide and cytarabine will be used as conditioning regimen for ASCT in the lymphoma patients. | Drug | Improved BEAM regimen |
Primary outcome
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
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Pengcheng He, MD 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 Improved BEAM regimen in people with Lymphoma and Autologous Hematopoietic Stem Cell Transplantation, 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 12 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengcheng He, MD (0086-029-85324035, hepc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 12 Jan 2023.