Newly Diagnosed Peripheral T-cell LymphomaPhase 3NCT05931263
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
A Phase 3 study testing C-BEAM Regimen and BEAM Regimen in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL. The main question it aims to answer are: •Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Newly Diagnosed Peripheral T-cell Lymphoma
- What is being tested?
- C-BEAM Regimen and BEAM Regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Feb 2028
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment;
- Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia.
- Age between 18 and 65 years old, male and female;
- ECOG physical strength score 0-1;
- Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight;
- Expected survival time ≥3 months;
- Voluntarily sign written informed consent.
Who cannot join
- Lymphoma involving the central nervous system
- Active hepatitis B or C virus infection;
- Active infection;
- HIV infected persons;
- Evidence of cirrhosis or liver fibrosis;
- Ecg showed QTc > 500ms;
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- Persons with mental disabilities/unable to obtain informed consent;
- Patients with drug or chronic alcohol abuse that may affect the evaluation of study results;
- Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures;
- The researcher determines that it is not suitable to participate in this 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, 1 recruiting
- Recruiting
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
Wei Xu, PhD, +86-2568302182, xuwei10000@hotmail.com
About this study
Official title: A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.
The main question it aims to answer are:
•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
Read the detailed description
This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)
- Being tested
- C-BEAM Regimen, BEAM Regimen
- Keywords
- PTCL, Chidemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-BEAM RegimenDrug
Chidemide，carmustine, etoposide, cytarabine, and melphalan
BEAM RegimenDrug
carmustine, etoposide, cytarabine, and melphalan
| Study group | Role | What they receive |
|---|---|---|
| C-BEAM | Experimental | Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation Receives: Drug: C-BEAM Regimen |
| BEAM | Sham comparator | carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation Receives: Drug: BEAM Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-y PFS
2-year PFS
Measured: 2 years
Secondary outcomes (4)
2-year OS
Measured: 2 years
CR rate at 3 months post-transplant evalutation
Measured: 2 years
hematopoietic reconstitution time
Measured: 2 years
Non-recurrent mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei xu, Principal investigator, : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931263
- Sponsor's protocol ID
- CSIIT-T29
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL
- ClinicalTrials.gov ID
- NCT05931263
- Acronym / sponsor ID
- CSIIT-T29
- Keywords
- PTCL, Chidemide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Jul 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.
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.
The main question it aims to answer are:
•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
Detailed description
This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-BEAM | Experimental | Drug: C-BEAM RegimenChidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation |
| BEAM | Sham comparator | Drug: BEAM Regimencarmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment;
- Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia.
- Age between 18 and 65 years old, male and female;
- ECOG physical strength score 0-1;
- Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight;
Key exclusion criteria (10 listed)
- Lymphoma involving the central nervous system
- Active hepatitis B or C virus infection;
- Active infection;
- HIV infected persons;
- Evidence of cirrhosis or liver fibrosis;
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 |
|---|---|---|
| C-BEAM RegimenChidemide，carmustine, etoposide, cytarabine, and melphalan | Drug | C-BEAM |
| BEAM Regimencarmustine, etoposide, cytarabine, and melphalan | Drug | BEAM |
Primary outcome
2-y PFS
Time frame: 2 years
2-year PFS
4 secondary outcomes
2-year OS
Time frame: 2 years
CR rate at 3 months post-transplant evalutation
Time frame: 2 years
hematopoietic reconstitution time
Time frame: 2 years
Non-recurrent mortality
Time frame: 2 years
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 5 Jul 2023.
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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.
wei xu principal investigator
: China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C-BEAM Regimen and BEAM Regimen in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 wei xu (86-25-68302182, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-y PFS (time frame: 2 years). 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 5 Jul 2023.