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Hodgkin LymphomaPhase 2NCT04239170

Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 study testing Camrelizumab(SHR-1210) in people with Hodgkin Lymphoma, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Camrelizumab(SHR-1210)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
Jan 2020to Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed classic Hodgkin's lymphoma ;
  • Relapsed or refractory cHL and meet any of the following criterions:a)did not achieve remission or progression and will receive autologous hematopoietic stem cell transplantation.b)receive no more than 3 lines of systemic chemotherapy.
  • Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  • ECOG performance status of 0 or 1;
  • Life expectancy ≥ 12 weeks.;
  • Adequate laboratory parameters during the screening period as evidenced by the following:
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  • Hemoglobin ≥ 90 g/L;
  • Absolute neutrophil count ≥ 1.5 × 109/L ;
  • Platelets ≥ 100 × 109/L;
  • Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
  • ALT and AST ≤ 2.5×ULN
  • Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
  • Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN
  • Women of childbearing potential（WOCBP）with pregnancy test negative within 7 days before entering the group and consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment; Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment.
  • Able to understand and sign an informed consent form (ICF).

Who cannot join

  • Known nodular lymphoma predominant Hodgkin lymphoma
  • History and complication as follows,
  • Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group
  • Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
  • Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
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  • Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
  • Known and highly Suspicion of interstitial pneumonia.
  • Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded).
  • 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.
  • Impact of major surgery or severe trauma had been eliminated for less than 28 days
  • Active pulmonary tuberculosis.
  • Severe acute or chronic infection requiring systemic therapy.
  • Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
  • Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months.
  • Three months before randomization, there were significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, stool occult blood test is ++ at baseline and above, or vasculitis
  • Laboratory test
  • Known HIV positive or known AIDS.
  • Untreated active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,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.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Yuqin Song, MD contact

(+8610)88196118

SongYQ_VIP@163.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Jun Zhu, MD, (+8610)88196596, Zj@bjcancer.org

    Recruiting

Other trials in China

About this study

Official title: An Open-lable, Single Arm, Phase 2 Study of Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Will Receive ASCT

This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria.

Being tested
Camrelizumab(SHR-1210)
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(SHR-1210)Drug

    Also called GEMOX(Gemcitabine, Oxaliplatin)

    Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin

Study groups in NCT04239170
Study groupRoleWhat they receive
Camrelizumab(SHR-1210) Combined With GEMOXExperimentalNot described
Receives: Drug: Camrelizumab(SHR-1210)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response

    Based on Lugano 2014 criteria

    Measured: From first patient first visit to 3 month after last patient first visit

Secondary outcomes (1)

  1. Objective Response Rate

    Rate of subjects achieved complete response plus partial response in all evaluable subjects

    Measured: From first patient first visit to 3 month after last patient first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study startJan 2020 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04239170
Sponsor's protocol ID
SHR-1210-GEMOX-IIT-HL
Status last verified
Jan 2020
First submitted
20 Jan 2020
Last updated
23 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Y, Ping L, Song Y, Tang Y, Zheng W, Liu W, Ying Z, Zhang C, Wu M, Feng F, Lin N, Tu M, Zhu J, Xie Y. Camrelizumab plus gemcitabine and oxaliplatin for relapsed or refractory classical Hodgkin lymphoma: a phase II trial. BMC Med. 2024 Mar 7;22(1):107. doi: 10.1186/s12916-024-03329-8.

    PubMed 38454451

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab(SHR-1210) in people with Hodgkin Lymphoma, run by Peking University 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 15 inclusion and 22 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 23 Jan 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 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?

Contact Yuqin Song, MD ((+8610)88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (time frame: From first patient first visit to 3 month after last patient first visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04239170, which also lists 1 linked publication.

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 23 Jan 2020.

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