Ineligible Or Refused Transplant Patients With Classical Hodgkin LymphomaPhase 2NCT06563778
Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.
A Phase 2 study testing Chidamide; Decitabine; Anti-PD-1 Antibody and Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody in people with Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
- What is being tested?
- Chidamide; Decitabine; Anti-PD-1 Antibody and Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2028
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1.18 to 75 years of age. 2.ECOG performance of less than 2. 3.Subjects must have histological confirmation classical Hodgkin lymphoma (cHL). 4. Patients must have at least two lines of antitumor therapy, those who were transplant-ineligible or refused transplant. 5.Life expectancy of at least 3 months. 6.Subjects with lymphoma must have at least one measureable lesion >1cm as defined by lymphoma response criteria. 7. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity. 8.Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 9.Subjects must have adequate marrow, live, renal and heart functions.
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Exclusion Criteria:1. Subjects have received the combination therapy of Chidamide+Decitabine and anti-PD-1 antibody or Brentuximab Vedotin + Bendamustine Plus Anti-PD-1 Antibody. 2.Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 3. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 4. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. 5. Prior organ allograft. 6. Women who are pregnant or breastfeeding. 7. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 8. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
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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
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Han W Weidong, Prfessor, 86-10-13651392893, hanwdrsw@sina.com
About this study
Official title: A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant
The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.
Read the detailed description
The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin or Bendamustine plus Anti-PD-1 Antibody are both standard regimens.The combination of Brentuximab Vedotin, Bendamustine and Anti-PD-1 Antibody may be another effective regimen. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody, in patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant .
The primary objective of the study is to evaluate the progression free survival. The key secondary end points are complete response rate, objective response rate and the safety.
- Being tested
- Chidamide; Decitabine; Anti-PD-1 Antibody, Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide; Decitabine; Anti-PD-1 AntibodyDrug
Chidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibodyDrug
Brentuximab Vedotin 1.2-1.8mg/kg day 1, Bendamustine 70-90mg/m2 day1-2, Anti-PD-1 antibody day 2. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide+Decitabine+ Anti-PD-1 Antibody | Experimental | Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Immune checkpoint inhibitors have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells. Receives: Drug: Chidamide; Decitabine; Anti-PD-1 Antibody |
| Brentuximab Vedotin+ Bendamustine+anti-PD-1 antibody | Active comparator | Not described Receives: Drug: Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
Measured: 2 years
Secondary outcomes (3)
Complete response rate (CRR)
CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Measured: 1 year
Objective response rate (ORR)
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria).
Measured: 1 year
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ineligible Or Refused Transplant Patients With Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563778
- Sponsor's protocol ID
- CHN-PLAGH-BT-089
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant
- ClinicalTrials.gov ID
- NCT06563778
- Acronym / sponsor ID
- CHN-PLAGH-BT-089
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Aug 2024 (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 prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.
Detailed description
The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin or Bendamustine plus Anti-PD-1 Antibody are both standard regimens.The combination of Brentuximab Vedotin, Bendamustine and Anti-PD-1 Antibody may be another effective regimen. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody, in patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant .
The primary objective of the study is to evaluate the progression free survival. The key secondary end points are complete response rate, objective response rate and the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide+Decitabine+ Anti-PD-1 Antibody | Experimental | Drug: Chidamide; Decitabine; Anti-PD-1 AntibodyChidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Immune checkpoint inhibitors have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells. |
| Brentuximab Vedotin+ Bendamustine+anti-PD-1 antibody | Active comparator | Drug: Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Chidamide; Decitabine; Anti-PD-1 AntibodyChidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment. | Drug | Chidamide+Decitabine+ Anti-PD-1 Antibody |
| Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibodyBrentuximab Vedotin 1.2-1.8mg/kg day 1, Bendamustine 70-90mg/m2 day1-2, Anti-PD-1 antibody day 2. Physicians will decide which immune checkpoint inhibitors will be used during treatment. | Drug | Brentuximab Vedotin+ Bendamustine+anti-PD-1 antibody |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 years
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
3 secondary outcomes
Complete response rate (CRR)
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Number of Subjects with treatment-related adverse events (AEs)
Time frame: 1 year
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 21 Aug 2024.
Related trials for Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
RecruitingPhase 2
Chidamide Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.
Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma
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.
1 site 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; Decitabine; Anti-PD-1 Antibody and Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody in people with Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma, run by Chinese PLA General Hospital 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?
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 21 Aug 2024. 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.
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?
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 Han W dong, Prfessor (01055499341, hanwdrsw@sina.com), or a site near the patient. 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 21 Aug 2024.