Hodgkin LymphomaPhase 2/3NCT04510610
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
A Phase 2/3 study testing Camrelizumab and Decitabine in people with Hodgkin Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Camrelizumab and Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Jan 2025
- Phase
- Phase 2/3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 2 12 to 75 years of age.
- 3 ECOG performance of less than 2.
- 4 Life expectancy of at least 3 months.
- 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- 6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- 7 Subjects must have adequate marrow, live, renal and heart functions.
Who cannot join
- 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- 4 Prior organ allograft.
- 5 Women who are pregnant or breastfeeding.
- 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
- 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, 100853
Weidong Han, 86-10-13651392893, hanwdrsw@sina.com
About this study
Official title: An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Camrelizumab and Decitabine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab and DecitabineDrug
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. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus decitabine | Experimental | Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks. Receives: Drug: Camrelizumab and Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of response
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Measured: 5 years
Progression free survival
Time measured from the day of treatment to the date of first documented progression, or death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Sep 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2025 (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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT04510610
- Sponsor's protocol ID
- CHN-PLAGH-BT-056
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04510610
- Acronym / sponsor ID
- CHN-PLAGH-BT-056
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Aug 2020 (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 is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory 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 |
|---|---|---|
| Camrelizumab plus decitabine | Experimental | Drug: Camrelizumab and DecitabineDecitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 2 12 to 75 years of age.
- 3 ECOG performance of less than 2.
- 4 Life expectancy of at least 3 months.
- 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
Key exclusion criteria (7 listed)
- 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- 4 Prior organ allograft.
- 5 Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| Camrelizumab and DecitabineDecitabine 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. Camrelizumab is a humanized anti-PD-1 monoclonal antibody. | Drug | Camrelizumab plus decitabine |
Primary outcome
duration of response
Time frame: 5 years
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Progression free survival
Time frame: 5 years
Time measured from the day of treatment to the date of first documented progression, or death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Camrelizumab and Decitabine in people with 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?
The sponsor lists 7 inclusion and 7 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 12 Aug 2020. 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 combined 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.
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?
Contact Weidong Han, M.D. (+861055499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of response (time frame: 5 years). The study lists 2 primary outcomes in all. 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 12 Aug 2020.