Classical Hodgkin LymphomaPhase 3NCT04342936
Study of Camrelizumab (SHR-1210) vs. Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
A Phase 3 study testing Camrelizumab and Investigator's choice of Chemotherapy in people with Classical Hodgkin Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Camrelizumab and Investigator's choice of Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2020to 1 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With histologically confirmed classic Hodgkin's lymphoma ;
- Relapsed or refractory cHL meet either of the following criteria:
- Did not achieve remission or progressed after autologous hematopoietic stem cell transplantation.
- Received at least 2 lines of systemic chemotherapy, failed to achieve remission or progressed after the most recent chemotherapy.
- Have measurable disease according to Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1;
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- Life expectancy ≥ 12 weeks;
- Has adequate organ function;
- Women of childbearing potential（WOCBP） must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
- Able to understand and sign an informed consent form (ICF).
Who cannot join
- Active, known or suspected autoimmune disease. Subjects who were in a stable state, do not need systemic immunosuppressive therapy were allowed to participate.
- Concurrent medical condition requiring the use of immunosuppressive medications or glucocorticoids exceeds a daily dose of 10mg prednisone or equivalent within 14 days before drug administration. Topical use of glucocorticoids is allowed.
- Received anti-tumor vaccines or other anti-tumor therapy with immune stimulatory effects within 3 months before the first dose SHR-1210.
- Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- Participating in other clinical studies or less than 4 weeks by the end of the most recent clinical trial participation;
- Known or suspected interstitial pneumonia;
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- Concurrent or history of other malignancies. (Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who received radical treatment and did not relapse in 5 years since treatment initiation).
- Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
- Prior allo-HSCT.
- ASCT within 90 days.
- Impact of major surgery or severe trauma had been eliminated for less than 14 days.
- Active pulmonary tuberculosis.
- Severe acute or chronic infection requiring systemic therapy.
- Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
- Live vaccine within 4 weeks before the first dose SHR-1210.Inactivated vaccines against seasonal influenza is allowed.Live attenuated influenza vaccines were not approved for intranasal administration.
- HIV test(s) positive or known AIDS.
- Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jianqiu Wu, M.D, +86 13951671579, drwujq@vip.126.com
Jifeng Feng, M.D, +86 13901581264, fjif@vip.sina.com
About this study
Official title: A Randomized,Open-label Phase III Study of Camrelizumab (SHR-1210) vs. Investigator's Choice of Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
This is an open-label, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice.
The primary hypotheses of this study are that treatment with Camrelizumab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Camrelizumab, Investigator's choice of Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called SHR-1210
A humanized monoclonal immunoglobulin
Investigator's choice of ChemotherapyDrug
Participants will receive one of the following chemotherapies for up to 6 cycles:
Gemox: Gemcitabine and Oxaliplatin； IGEV: Ifosfamide, Gemcitabine, Vinorelbine, and Prednisolone； DHAP: Dexamethasone, high-dose Cytarabine (Ara-C) and Cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab for Injection | Experimental | Participants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle Receives: Drug: Camrelizumab |
| Chemotherapy | Active comparator | Participants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles. Receives: Drug: Investigator's choice of Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from randomisation to radiologically confirmed progressive disease
Measured: anticipated 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start17 Jul 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342936
- Sponsor's protocol ID
- SHR-1210-III-317
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open-label Phase III Study of Camrelizumab (SHR-1210) vs. Investigator's Choice of Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
- ClinicalTrials.gov ID
- NCT04342936
- Acronym / sponsor ID
- SHR-1210-III-317
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Apr 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, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice.
The primary hypotheses of this study are that treatment with Camrelizumab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab for Injection | Experimental | Drug: CamrelizumabParticipants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle |
| Chemotherapy | Active comparator | Drug: Investigator's choice of ChemotherapyParticipants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- With histologically confirmed classic Hodgkin's lymphoma ;
- Relapsed or refractory cHL meet either of the following criteria:
- Have measurable disease according to Lugano 2014 criteria
- Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1;
- Life expectancy ≥ 12 weeks;
Key exclusion criteria (18 listed)
- Active, known or suspected autoimmune disease. Subjects who were in a stable state, do not need systemic immunosuppressive therapy were allowed to participate.
- Concurrent medical condition requiring the use of immunosuppressive medications or glucocorticoids exceeds a daily dose of 10mg prednisone or equivalent within 14 days before drug administration. Topical use of glucocorticoids is allowed.
- Received anti-tumor vaccines or other anti-tumor therapy with immune stimulatory effects within 3 months before the first dose SHR-1210.
- Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- Participating in other clinical studies or less than 4 weeks by the end of the most recent clinical trial participation;
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210A humanized monoclonal immunoglobulin | Drug | Camrelizumab for Injection |
| Investigator's choice of ChemotherapyParticipants will receive one of the following chemotherapies for up to 6 cycles: Gemox: Gemcitabine and Oxaliplatin； IGEV: Ifosfamide, Gemcitabine, Vinorelbine, and Prednisolone； DHAP: Dexamethasone, high-dose Cytarabine (Ara-C) and Cisplatin. | Drug | Chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: anticipated 16 months
Time from randomisation to radiologically confirmed progressive disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Classical Hodgkin Lymphoma
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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 3 study testing Camrelizumab and Investigator's choice of Chemotherapy in people with Classical Hodgkin Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. 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 10 inclusion and 18 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 8 Feb 2021. 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 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 Weiwei Wang, Ph.D. (86-021-23511999, wangweiwei@hrglobe.cn), 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: anticipated 16 months). 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 8 Feb 2021.