Classic Hodgkin's LymphomaPhase 3NCT04044222
A Study to Evaluate the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus ICE Regimen in Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed First-line Standard Chemotherapy
A Phase 3 study testing Sintilimab, Carboplatin and Etoposide in people with Classic Hodgkin's Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin's Lymphoma
- What is being tested?
- Sintilimab, Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2019to 31 Dec 2024
- 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
- Signed informed consent
- Histopathologically confirmed cHL
- Failed first-line standard combination chemotherapy
- One measurable lesion (Lugano 2014)
- Eastern Cooperative Oncology Group (ECOG) of 0-1
- Male or female aged ≥18 years
- Patients must have adequate organ and bone marrow function
Who cannot join
- Patients must not have known central nervous system (CNS) involvement
- Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
- Patients may not simultaneously participate in another interventional clinical study
- Patients may not receive any other investigational agents within 4 weeks of study registration
- Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
- Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period)
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- Patients with known immunodeficiency are ineligible
- Patients with known active TB (Bacillus tuberculosis) are ineligible
- Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
- Patients must not be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi, 010-87788293, syuankaipumc@126.com
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure
This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.
Read the detailed description
randomized, double-blind, two arms , multicenter
- Conditions
- Classic Hodgkin's Lymphoma
- Being tested
- Sintilimab, Carboplatin, Etoposide, Ifosfamide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabBiological
IV
CarboplatinDrug
IV
EtoposideDrug
IV
IfosfamideDrug
IV
PlaceboDrug
IV
CarboplatinDrug
IV
EtoposideDrug
IV
IfosfamideDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) | Experimental | Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses. Receives: Biological: Sintilimab; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide |
| Treatment (placebo, etoposide, ifosfamide, carboplatin) | Experimental | Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses. Receives: Drug: Placebo; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 44months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start21 Oct 2019
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044222
- Sponsor's protocol ID
- CIBI308B301
- Status last verified
- Sep 2022
- First submitted
- 1 Aug 2019
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure
- ClinicalTrials.gov ID
- NCT04044222
- Acronym / sponsor ID
- CIBI308B301
- Conditions
- Classic Hodgkin's Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Aug 2019 (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 phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.
Detailed description
randomized, double-blind, two arms , multicenter
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) | Experimental | Biological: Sintilimab, Drug: Carboplatin, Drug: Etoposide, Drug: IfosfamidePatients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses. |
| Treatment (placebo, etoposide, ifosfamide, carboplatin) | Experimental | Drug: Placebo, Drug: Carboplatin, Drug: Etoposide, Drug: IfosfamidePatients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Histopathologically confirmed cHL
- Failed first-line standard combination chemotherapy
- One measurable lesion (Lugano 2014)
- Eastern Cooperative Oncology Group (ECOG) of 0-1
Key exclusion criteria (10 listed)
- Patients must not have known central nervous system (CNS) involvement
- Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
- Patients may not simultaneously participate in another interventional clinical study
- Patients may not receive any other investigational agents within 4 weeks of study registration
- Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
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 |
|---|---|---|
| SintilimabIV | Biological | Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) |
| CarboplatinIV | Drug | Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) |
| EtoposideIV | Drug | Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) |
| IfosfamideIV | Drug | Treatment (Sintilimab, etoposide, ifosfamide, carboplatin) |
| PlaceboIV | Drug | Treatment (placebo, etoposide, ifosfamide, carboplatin) |
| CarboplatinIV | Drug | Treatment (placebo, etoposide, ifosfamide, carboplatin) |
| EtoposideIV | Drug | Treatment (placebo, etoposide, ifosfamide, carboplatin) |
| IfosfamideIV | Drug | Treatment (placebo, etoposide, ifosfamide, carboplatin) |
Primary outcome
PFS
Time frame: 44months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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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 Sintilimab, Carboplatin and Etoposide in people with Classic Hodgkin's Lymphoma, run by Innovent Biologics (Suzhou) 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 7 inclusion and 10 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 14 Sep 2022. 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 Ronghua Zhang (15267110561, ronghua.zhang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 44months). 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 14 Sep 2022.