Lymphoma, Large B-Cell, DiffusePhase 3NCT05466318
ChiCGB vs BEAM in High-risk or R/R Lymphomas
A Phase 3 study testing Chidamide, Cladribine and Gemcitabine in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, T-Cell, run by Sichuan University at 11 sites in China.
Trial summary
High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
- What is being tested?
- Chidamide, Cladribine and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 11 sitesChina
- Study dates
- 1 Jul 2022to 30 Dec 2025
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.
- Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Who cannot join
- Central nervous system lymphoma
- Patients relapsed after autologous stem cell transplantation
- Bone marrow was involved by lymphoma
- Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
- Active infection requiring parenteral antibiotics
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Patients with a corrected QT interval(QTc) longer than 500 ms
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Chengdu Third People's Hospital
Chengdu, Sichuan, 610015
Jing Tan, MD, 86-28-84446038, JingT@sina.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jie Ji, MD, 86-28-85422373, jijie@wchscu.cn
- Recruiting
Chengdu First People's Hospital
Chengdu, Sichuan, 610071
Kaiji Zhang, MD, +86 028-85311726, kaijiZ@163.com
- Recruiting
PLA Western Theater Command General Hospital
Chengdu, Sichuan, 610083
Hai Yi, MD, 86-028-86570211, HaiYiCD@163.com
- Not yet recruiting
Dazhou Central Hospital
Dazhou, Sichuan, 635000
Yaqiong Li, MD, 86-0818-2371651, yqli@163.com
- Not yet recruiting
People's Hospital of Deyang City
Deyang, Deyang, 618000
Jie Zhou, MD, 86-0838-2418820, JieZhou@163.com
- Recruiting
Guangyuan Central Hospital
Guangyuan, Sihcuan, 628099
Ying Yuan, MD, 86-0839-3611120, dryingyuan@163.com
- Recruiting
Southwest Medical University
Luzhou, Sichuan, 646000
Hongyun Xing, MD, 86-0830-3161222, hyxing@gmail.com
- Recruiting
Central Hospital of Mianyang City
Mianyang, Sichuan, 621000
Fang Xu, MD, +86 816 222 2566, DrFangX@163.com
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Xingli Zou, MD, 86-0817-2239379, XingliZ@sina.com
- Recruiting
Zigong First People's Hospital
Zigong, Sichuan, 643011
Jian Xiao, MD, +86 813 210 0694, xiaojian@163.com
About this study
Official title: ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial
High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
- Being tested
- Chidamide, Cladribine, Gemcitabine, Busulfan, Carmustine
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
30 mg oral twice weekly for 2 weeks
CladribineDrug
6 mg/m2 intravenously once daily @ Day -7 ~ -3
GemcitabineDrug
2500 mg/m2 intravenously @ Day -7, -3
BusulfanDrug
3.2 mg/kg intravenously once daily @ Day -7 ~ -4
CarmustineDrug
300 mg/m2 intravenously @ Day -8
EtoposideDrug
200 mg/m2 intravenously once daily @ Day -7 ~ -4
CytarabineDrug
400 mg/m2 intravenously once daily @ Day -7 ~ -4
MelphalanDrug
140 mg/m2 intravenously @ Day -3
Autologous hematopoietic stem cell transplantProcedure or surgery
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ChiCGB | Experimental | Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. Receives: Drug: Chidamide; Drug: Cladribine; Drug: Gemcitabine; Drug: Busulfan; Procedure: Autologous hematopoietic stem cell transplant |
| BEAM | Active comparator | Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. Receives: Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Procedure: Autologous hematopoietic stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Measured: 2 years
Secondary outcomes (3)
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Measured: 2 years
100 day adverse events (AE)
non-hematologic adverse events @ Day +100
Measured: 100 days from transplant
100 day complete response (CR) rate
Complete response @ Day +100
Measured: 100 days from transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Sichuan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466318
- Sponsor's protocol ID
- ChiCGB 2.0
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Release after the publication of results of this trial
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05466318
- Acronym / sponsor ID
- ChiCGB 2.0
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jul 2022 (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.
High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChiCGB | Experimental | Drug: Chidamide, Drug: Cladribine, Drug: Gemcitabine, Drug: Busulfan, Procedure: Autologous hematopoietic stem cell transplantTreated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. |
| BEAM | Active comparator | Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: Melphalan, Procedure: Autologous hematopoietic stem cell transplantTreated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.
Key exclusion criteria (8 listed)
- Central nervous system lymphoma
- Patients relapsed after autologous stem cell transplantation
- Bone marrow was involved by lymphoma
- Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
- Active infection requiring parenteral antibiotics
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 |
|---|---|---|
| Chidamide30 mg oral twice weekly for 2 weeks | Drug | ChiCGB |
| Cladribine6 mg/m2 intravenously once daily @ Day -7 ~ -3 | Drug | ChiCGB |
| Gemcitabine2500 mg/m2 intravenously @ Day -7, -3 | Drug | ChiCGB |
| Busulfan3.2 mg/kg intravenously once daily @ Day -7 ~ -4 | Drug | ChiCGB |
| Carmustine300 mg/m2 intravenously @ Day -8 | Drug | BEAM |
| Etoposide200 mg/m2 intravenously once daily @ Day -7 ~ -4 | Drug | BEAM |
| Cytarabine400 mg/m2 intravenously once daily @ Day -7 ~ -4 | Drug | BEAM |
| Melphalan140 mg/m2 intravenously @ Day -3 | Drug | BEAM |
| Autologous hematopoietic stem cell transplantautologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy | Procedure or surgery | BEAM, ChiCGB |
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
Progression free survival of this group of patients at the end of 2 year
3 secondary outcomes
Overall survival (OS)
Time frame: 2 years
100 day adverse events (AE)
Time frame: 100 days from transplant
100 day complete response (CR) rate
Time frame: 100 days from transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: Yes. Release after the publication of results of this trial
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chidamide, Cladribine and Gemcitabine in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, T-Cell, run by Sichuan University at 11 sites 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 8 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (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 25 Jul 2022.