Hodgkin LymphomaPhase 2NCT03602131
Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma
A Phase 2 study testing Chidamide, Cladribine and gemcitabine in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Sichuan University.
Trial summary
This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Hodgkin Lymphoma, Non-hodgkin 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Mar 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 15 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, mantle cell lymphoma, peripheral T cell lymphomas, Hodgkin lymphomas 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
About this study
Official title: Chidamide Combined With Cladribine/Gemcitabine/Busulfan (ChiCGB) With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma
This study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Being tested
- Chidamide, Cladribine, gemcitabine, Busulfan, Autologous hematopoietic stem cell transplantation
- Keywords
- Chidamide, autologous stem cell transplantation
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
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 for 5 days
gemcitabineDrug
2500 mg/m2 intravenously twice weekly for 1 week
BusulfanDrug
3.2 mg/kg intravenously once 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 | 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 transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression free survival
Measured: 2 years from recruitment
Secondary outcomes (3)
2-year overall survival
Measured: 2 years from recruitment
Treatment related mortality
Measured: 2 years from recruitment
non-hematologic adverse events
Measured: 2 years from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03602131
- Sponsor's protocol ID
- ChiCGB-HR lymphomas
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 26 Jul 2018
- 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 26 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 High-risk Hodgkin and Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03602131
- Acronym / sponsor ID
- ChiCGB-HR lymphomas
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Keywords
- Chidamide, autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 26 Jul 2018 (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 study is to explore the efficacy and safety of ChiCGB conditioning therapy in patients with high-risk Hodgkin and non-Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChiCGB | Experimental | Drug: Chidamide, Drug: Cladribine, Drug: gemcitabine, Drug: Busulfan, Procedure: Autologous hematopoietic stem cell transplantationTreated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- 15 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, mantle cell lymphoma, peripheral T cell lymphomas, Hodgkin lymphomas 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 for 5 days | Drug | ChiCGB |
| gemcitabine2500 mg/m2 intravenously twice weekly for 1 week | Drug | ChiCGB |
| Busulfan3.2 mg/kg intravenously once daily for 4 days | Drug | ChiCGB |
| Autologous hematopoietic stem cell transplantationautologous hematopoietic stem cells infusion after ChiCGB chemotherapy | Procedure or surgery | ChiCGB |
Primary outcome
2-year progression free survival
Time frame: 2 years from recruitment
3 secondary outcomes
2-year overall survival
Time frame: 2 years from recruitment
Treatment related mortality
Time frame: 2 years from recruitment
non-hematologic adverse events
Time frame: 2 years from recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Cladribine and gemcitabine in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Sichuan University.
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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression free survival (time frame: 2 years from recruitment). 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 26 Jul 2018.