LymphomaPhase 2NCT03151876
Chidamide Combined With Clad/Gem/Bu With AutoSCT in R/R Diffuse Large B Cell Lymphoma
A Phase 2 study testing Chidamide, Cladribine and gemcitabine in people with Lymphoma, run by Sichuan University at 18 sites in China.
Trial summary
The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB regimen( chidamide, cladribine, gemcitabine and busulfan). Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- 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
- 93 participants
- Where
- 18 sitesChina
- Study dates
- 12 Jun 2017to Dec 2021
- Phase
- Phase 2
- 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
- Patients with primary refractory or recurrent diffuse large B 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 PR before recruitment.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- 6. 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.
- 7. 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.
- 8. Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- 9. Performance status 0-1. 10. Negative Beta diffusing capacity of 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 ASCT
- 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 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 cQT longer than 500 ms
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
Yan Xie, MD
- Not yet recruiting
Peking university third hospital
Beijing, Beijing Municipality, 100191
Xiaoyan Ke, MD
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Jie Ji, MD, 86-28-85422370, jieji@scu.edu.cn
- Not yet recruiting
The first affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, 400016
Lin Liu, MD
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Dabing Qin, MD
- Not yet recruiting
Kunming General Hospital of Chengdu Military Area
Kunming, Yunnan, 650032
Sanbin Wang, MD
- Not yet recruiting
General Hospital of Lanzhou military command
Lanzhou, Gansu, 730070
Hai Bai, MD
- Recruiting
Affiliated Hospital of Southwest Medical University
Nanchong, Sichuan, 646000
Xiaoming Li, MD
- Not yet recruiting
Jiangsu province hospital
Nanjing, Jiangsu, 210029
Wei Xu, MD
- Not yet recruiting
Rui jin hospital Shanghai jiao tong University
Shanghai, Shanghai Municipality, 200025
Jiong Hu, MD
- Not yet recruiting
Tong Ren Hospital
Shanghai, Shanghai Municipality
Ligen L i u, MD
- Not yet recruiting
Shan Xi Da Yi Hospital
Taiyuan, Shanxi, 030032
Rong Gong, MD
- Not yet recruiting
Blood diseases hospital, Chinese academy of medica
Tianjin, Tianjing, 300020
Lvgui Qiu, MD
- Not yet recruiting
The first affiliated hospital of Xinjiang medical Universtiy
Ürümqi, Xinjiang, 830054
Ming Jiang, MD
- Not yet recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yang Cao, MD
- Not yet recruiting
Tangdu Hospital
Xi’an, Shanxi, 710038
Qiang Liu, MD
- Not yet recruiting
Henan cancer hospital
Zhengzhou, Henan, 450008
Jian Zhou, MD
- Not yet recruiting
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450052
Xinhua Wang, MD
About this study
Official title: Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in Relapsed and Refractory Diffuse Large B Cell Lymphoma
The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB regimen( chidamide, cladribine, gemcitabine and busulfan).
Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die.
Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan.
Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as cladribine, gemcitabine, busulfan.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving the study drugs.
The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next dose level until either the vorinostat reaches the dose level currently used alone without stem cell transplant, or the highest tolerable dose of this drug is found. The dose that you receive will remain the same throughout this study.
You will be admitted to the hospital on Day -6.
Study Drug Administration (for all patients):
In stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive your stem cells are called plus days.
On Day -7, -4, 0, +3 , you will take chidamide by mouth.
On Days -6, -5, -4, -3, and -2 you will receive cladribine by vein over 1/2 hours.
On Day -6, -2, you will receive gemcitabine by vein over 3 1/2 - 4 1/2 hours.
On Days -6, -5, -4, and -3, you will receive busulfan by vein over 3 hours.
On Day -1, you will rest.
On Day 0, you will receive your stem cells by vein over about 30-60 minutes.
As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin twice a day starting on Day +5 until your blood cell levels return to normal.
Study Tests:
On Day -1, you will have an electrocardiogram (ECG) to check your heart function.
About 30-100 days after the transplant, you will have lung function tests.
About 100 days after the transplant:
Blood (about 4 teaspoons) will be drawn for routine tests. If the doctor thinks it is needed, you may have a bone marrow aspiration and biopsy to check the status of the disease.
You will have a PET/CT scan of your whole body to check the status of the disease.
Length of Study:
As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are released from the hospital, you will continue as an outpatient for infections and transplant-related complications.
You will be taken off study about 100 days after the transplant. You may be taken off study early if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Chidamide, gemcitabine, busulfan, melphalan, and rituximab are all FDA approved and commercially available. The use of these study drugs in combination is investigational.
Up to 93 patients will take part in this study.
- Conditions
- Lymphoma
- Being tested
- Chidamide, Cladribine, gemcitabine, Busulfan, Autologous hematopoietic stem cell transplantation
- Medical subject headings
- Lymphoma
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 daily for 5 days
gemcitabineDrug
2500 mg/m2 intravenously twice weekly for 1 week
BusulfanDrug
3.2 mg/kg intravenously daily for 4 days
Autologous hematopoietic stem cell transplantationProcedure or surgery
autologous hematopoietic stem cells infusion after ChiCGB chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ChiCGB | Experimental | Experimental: ChiCGB
Chidamide administered orally on D-7, -4, 0,+3
Cladribine administered at 10mg on D-6 to D-2
Gemcitabine administered at 2500 mg/m2 on days -6 and -2.
Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3.
Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8.
Interventions:
Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant Receives: Drug: Chidamide; Drug: Cladribine; Drug: gemcitabine; Drug: Busulfan; Procedure: Autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 2 years
Complete remission
Measured: 3 month after autologous hematopoietic stem cell transplantation
Adverse events
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 posted12 May 2017
- Study start12 Jun 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ChiCGB
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
- Investigators
- Ting Liu, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151876
- Sponsor's protocol ID
- ChiCGB-DLBCL
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: electronic case report form (eCRF)
Publications
Ji J, Liu Z, Kuang P, Dong T, Chen X, Li J, Zhang C, Liu J, Zhang L, Shen K, Liu T. A new conditioning regimen with chidamide, cladribine, gemcitabine and busulfan significantly improve the outcome of high-risk or relapsed/refractory non-Hodgkin's lymphomas. Int J Cancer. 2021 Dec 15;149(12):2075-2082. doi: 10.1002/ijc.33761. Epub 2021 Aug 25.
PubMed 34398971
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in Relapsed and Refractory Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03151876
- Acronym / sponsor ID
- ChiCGB-DLBCL
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 May 2017 (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 research study is to evaluate effectiveness and safety of ChiCGB regimen( chidamide, cladribine, gemcitabine and busulfan).
Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die.
Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan.
Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as cladribine, gemcitabine, busulfan.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving the study drugs.
The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next dose level until either the vorinostat reaches the dose level currently used alone without stem cell transplant, or the highest tolerable dose of this drug is found. The dose that you receive will remain the same throughout this study.
You will be admitted to the hospital on Day -6.
Study Drug Administration (for all patients):
In stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive your stem cells are called plus days.
On Day -7, -4, 0, +3 , you will take chidamide by mouth.
On Days -6, -5, -4, -3, and -2 you will receive cladribine by vein over 1/2 hours.
On Day -6, -2, you will receive gemcitabine by vein over 3 1/2 - 4 1/2 hours.
On Days -6, -5, -4, and -3, you will receive busulfan by vein over 3 hours.
On Day -1, you will rest.
On Day 0, you will receive your stem cells by vein over about 30-60 minutes.
As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin twice a day starting on Day +5 until your blood cell levels return to normal.
Study Tests:
On Day -1, you will have an electrocardiogram (ECG) to check your heart function.
About 30-100 days after the transplant, you will have lung function tests.
About 100 days after the transplant:
Blood (about 4 teaspoons) will be drawn for routine tests. If the doctor thinks it is needed, you may have a bone marrow aspiration and biopsy to check the status of the disease.
You will have a PET/CT scan of your whole body to check the status of the disease.
Length of Study:
As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are released from the hospital, you will continue as an outpatient for infections and transplant-related complications.
You will be taken off study about 100 days after the transplant. You may be taken off study early if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Chidamide, gemcitabine, busulfan, melphalan, and rituximab are all FDA approved and commercially available. The use of these study drugs in combination is investigational.
Up to 93 patients will take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ChiCGB
| Arm | Type | Receives |
|---|---|---|
| ChiCGB | Experimental | Drug: Chidamide, Drug: Cladribine, Drug: gemcitabine, Drug: Busulfan, Procedure: Autologous hematopoietic stem cell transplantationExperimental: ChiCGB Chidamide administered orally on D-7, -4, 0,+3 Cladribine administered at 10mg on D-6 to D-2 Gemcitabine administered at 2500 mg/m2 on days -6 and -2. Busulfan administered at 3.2 mg/kg (adjusted ideal body weight) on days -6 to -3. Dexamethasone 10 mg by vein daily from day -6 to day -1. Caphosol oral rinses 30 mL four times a day used from day -8. Interventions: Drug: Chidamide Drug: Cladribine Drug: Gemcitabine Drug: Busulfan Drug: Dexamethasone Procedure: Stem Cell Transplant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with primary refractory or recurrent diffuse large B 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 PR before recruitment.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- 6. 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.
- 7. 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 ASCT
- 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 daily for 5 days | Drug | ChiCGB |
| gemcitabine2500 mg/m2 intravenously twice weekly for 1 week | Drug | ChiCGB |
| Busulfan3.2 mg/kg intravenously daily for 4 days | Drug | ChiCGB |
| Autologous hematopoietic stem cell transplantationautologous hematopoietic stem cells infusion after ChiCGB chemotherapy | Procedure or surgery | ChiCGB |
Primary outcome
Event free survival
Time frame: 2 years
3 secondary outcomes
Overall survival
Time frame: 2 years
Complete remission
Time frame: 3 month after autologous hematopoietic stem cell transplantation
Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 34398971Ji J, Liu Z, Kuang P, Dong T, Chen X, Li J, Zhang C, Liu J, Zhang L, Shen K, Liu T. A new conditioning regimen with chidamide, cladribine, gemcitabine and busulfan significantly improve the outcome of high-risk or relapsed/refractory non-Hodgkin's lymphomas. Int J Cancer. 2021 Dec 15;149(12):2075-2082. doi: 10.1002/ijc.33761. Epub 2021 Aug 25.
- Individual participant dataSharing planned: Yes. electronic case report form (eCRF)
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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.
Ting Liu, MD principal investigator
West China Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Cladribine and gemcitabine in people with Lymphoma, run by Sichuan University at 18 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jie Ji, MD (86-28-85422370, JieJi@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151876, which also lists 1 linked publication.
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 Jul 2018.