ClinicalTrials.gg
Status unknownNCT04239170Updated Jan 23, 2020

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

A Phase 2 interventional study of Camrelizumab(SHR-1210) in Hodgkin Lymphoma, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Peking University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hodgkin Lymphoma

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03

In context

Hodgkin Disease

914 studies on the registry are indexed under Hodgkin Disease; 136 are open to participants now.

This study's planned enrollment of 84 is above the median of 43 across 746 interventional studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Peking University is the lead sponsor of 418 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histologically confirmed classic Hodgkin's lymphoma ;
  2. 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.
  3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  4. ECOG performance status of 0 or 1;
  5. Life expectancy ≥ 12 weeks.;
  6. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Hemoglobin ≥ 90 g/L;
    2. Absolute neutrophil count ≥ 1.5 × 109/L ;
    3. Platelets ≥ 100 × 109/L;
    4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
    5. ALT and AST ≤ 2.5×ULN
    6. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
    7. Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
  7. 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.
  8. Able to understand and sign an informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

  1. Known nodular lymphoma predominant Hodgkin lymphoma
  2. History and complication as follows,

    1. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
    2. 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
    3. Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
    4. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
    5. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
    6. Known and highly Suspicion of interstitial pneumonia.
    7. 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).
    8. 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.
    9. Prior allo-HSCT.
    10. Impact of major surgery or severe trauma had been eliminated for less than 28 days
    11. Active pulmonary tuberculosis.
    12. Severe acute or chronic infection requiring systemic therapy.
    13. Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
    14. 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.
    15. 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
  3. Laboratory test

    1. Known HIV positive or known AIDS.
    2. 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.
  4. 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.
  5. Pregnant or lactating women.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Camrelizumab(SHR-1210) Combined With GEMOX

    Drug: Camrelizumab(SHR-1210)

Interventions

  • Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin

    Also known as: GEMOX(Gemcitabine, Oxaliplatin)

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What researchers measure

Primary outcomes

  1. Complete Response

    Based on Lugano 2014 criteria

    Time frame: From first patient first visit to 3 month after last patient first visit

Secondary outcomes

  1. Objective Response Rate

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

    Time frame: From first patient first visit to 3 month after last patient first visit

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Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality, China
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2020; primary completion for Dec 2022, 35 months later.

Of 134 non-industry phase 2 interventional studies under Hodgkin Disease, half reached primary completion within 78 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 111. This study's planned 35 months is below that.

Counting every sponsor, half of 156 studies reached it within 66 months; a quarter within 40 and three quarters within 108.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2020
First posted
Jan 23, 2020
StartEst.
Jan 2020
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2022
Last update
Jan 23, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04239170
Lead sponsor
Peking University
Responsible party
Jun Zhu (Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine, Peking University) — Principal investigator
First posted
Jan 23, 2020
Start date
Jan 2020 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 23, 2020

Study contacts

Yuqin Song, MD
Contact
SongYQ_VIP@163.com
(+8610)88196118

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Camrelizumab

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