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Hodgkin LymphomaPhase 2NCT03250962

SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 study testing SHR-1210 and Decitabine in people with Hodgkin Lymphoma, run by Chinese PLA General Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of… 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?
SHR-1210 and Decitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
11 Sep 2017to 21 Mar 2025
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 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 four prior chemotherapy regimen, 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.Subjects with Anti-PD-1 antibody are eligible which must be resistance.
  • 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 investigational 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

  • Biotherapeutic Department of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Weidong Han, M.D, +86-10-66937463, hanwdrsw@sina.com

    Qingming Yang, M.D, +86-10-55499341, yangqm@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: Anti-PD-1 Antibody SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase II Trial

This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the above two groups), the stage II study will be revised to a multicohort, decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or refractory Hodgkin Lymphoma.

Being tested
SHR-1210, Decitabine
Keywords
Relapsed/Refractory; Hodgkin Lymphoma；Decitabine; SHR-1210
Medical subject headings
Hodgkin Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

  • 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.

Study groups in NCT03250962
Study groupRoleWhat they receive
SHR-1210-plus-DecitabineExperimentalDecitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
Receives: Drug: SHR-1210; Drug: Decitabine
SHR-1210ExperimentalSHR-1210 200 mg, day 1, every 3 weeks.
Receives: Drug: SHR-1210

What is being measured

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

  1. stage I: Number of Subjects with treatment-related adverse events (AEs)

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

    Measured: 2 years

  2. stage I: CRR assess by investigators per the 2014 Lugano classification

    rate of subjects achieved complete response in all evaluable subjects

    Measured: 3 years

  3. stage II: duration of CR

    Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.

    Measured: 5 years

Secondary outcomes (2)

  1. stage II: 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

  2. stage II: 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.

  1. First posted16 Aug 2017
  2. Study start11 Sep 2017
  3. Primary completion21 Jul 2022 (estimated)
  4. Study completion21 Mar 2025 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250962
Sponsor's protocol ID
CHN-PLAGH-BT-023
Status last verified
Mar 2019
First submitted
10 Aug 2017
Last updated
1 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study Protocol

Publications

  • Liu Y, Wang C, Li X, Dong L, Yang Q, Chen M, Shi F, Brock M, Liu M, Mei Q, Liu J, Nie J, Han W. Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma. J Immunother Cancer. 2021 Apr;9(4):e002347. doi: 10.1136/jitc-2021-002347.

    PubMed 33820822

  • Wang C, Liu Y, Dong L, Li X, Yang Q, Brock MV, Mei Q, Liu J, Chen M, Shi F, Liu M, Nie J, Han W. Efficacy of Decitabine plus Anti-PD-1 Camrelizumab in Patients with Hodgkin Lymphoma Who Progressed or Relapsed after PD-1 Blockade Monotherapy. Clin Cancer Res. 2021 May 15;27(10):2782-2791. doi: 10.1158/1078-0432.CCR-21-0133. Epub 2021 Mar 5.

    PubMed 33674274

  • Nie J, Wang C, Liu Y, Yang Q, Mei Q, Dong L, Li X, Liu J, Ku W, Zhang Y, Chen M, An X, Shi L, Brock MV, Bai J, Han W. Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2019 Jun 10;37(17):1479-1489. doi: 10.1200/JCO.18.02151. Epub 2019 Apr 30.

    PubMed 31039052

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 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 4 inclusion and 5 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 1 Apr 2019. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stage I: Number of Subjects with treatment-related adverse events (AEs) (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT03250962, which also lists 3 linked publications.

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 1 Apr 2019.

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