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Relapsed/Refractory Classical Hodgkin's LymphomaPhase 2ORIENT-1NCT03114683

Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

A Phase 2 study testing PD1 in people with Relapsed/Refractory Classical Hodgkin's Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of patients with Relapsed/Refractory Hodgkin's Lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PD1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
30 Mar 2017to 30 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histopathological confirmed classical Hodgkin's lymphoma (cHL).
  • Relapsed/refractory cHL, which failed second line and above therapy (including radiotherapy and autologous hematopoietic stem cell transplantation, ASCT); subject with no response to or with progression after ASCT is eligible.
  • At least one measurable disease (long axis>15 mm or short axis>10 mm, with uptake on 18FDG-PET)
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
  • Signed written informed consent form and willing and able to comply with scheduled visits and other requirements of the study.
  • Age ≥ 18.
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  • Life expectancy of at least 12 weeks.
  • Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 90 days after the last dose of study medication.
  • Adequate organ and bone marrow function:
  • Count of Blood Cells: absolute neutrophil count (ANC) ≥ 0.75 × 109 / L; platelet count (PLT) ≥ 50 × 109 / L; hemoglobin content (HGB) ≥ 8.0 g / dL; no granulocyte colony-stimulating factor, platelet or red blood cells infusion in the last 14 days.
  • Liver function: total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
  • Renal function: serum creatinine (Cr) ≤ 1.5 × ULN.
  • Thyroid function: thyroid stimulating hormone (TSH) in normal range (TSH abnormalities due to non-autoimmune causes can be enrolled).

Who cannot join

  • Known nodular lymphocyte predominant Hodgkin lymphoma.
  • Known central nervous system lymphoma.
  • Received ASCT within 90 days of the first dose of study medication.
  • Prior exposure to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
  • Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study.
  • Received any investigational agent within 4 weeks of the first dose of study medication.
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  • Received last dose of radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication; received last dose of nitrosourea or mitomycin C within 6 weeks of the first dose of study medication.
  • Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Underwent major operation (craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
  • Activated, known or suspected autoimmune diseases or history of the disease with two years before enrollment. Vitiligo, psoriasis, hair loss, or Graves disease which do not need systemic treatment in 2 years, or hypothyroidism which only need thyroid hormone replacement therapy, or type-1 diabetes which only need insulin replacement therapy is eligible for enrollment.
  • Known primary immunodeficiency disorders.
  • Active tuberculosis.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
  • Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation.
  • Uncontrolled concomitant disease, including but not limited to :
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
  • Active or poorly controlled severe infection
  • Symptomatic congestive heart failure (New York Heart Association grade Ⅲ-IV) or symptomatic, poorly controlled arrhythmia
  • Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) with standard treatment
  • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke or transient ischemic attack, within 6 months before enrollment
  • Prior life-threatening blood loss or grade 3/4 gastrointestinal/varicosity bleeding requiring blood infusion, endoscopic or surgical intervention within 3 months of enrollment
  • Prior deep vein thrombosis, pulmonary embolism or any other severe thromboembolism events (implanted port or catheter caused thrombosis, or superficial vein thrombosis are not considered as severe thromboembolism events) within 3 months before enrollment
  • History of uncontrolled metabolic disorder, non-malignant organ or systemic disease or secondary carcinomatous reaction, with high medical risk and/or uncertainty of survival evaluation
  • With hepatic encephalopathy, hepato-renal syndrome or hepatic cirrhosis of Child-Pugh grade B or higher.
  • History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colonic resection or extensive small bowel resection, concomitant with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study
  • Known acute or chronic active hepatitis B infection (chronic HBV carrier or non-active HBsAg positive subject is eligible) or acute or chronic active hepatitis C (HCV antibody negative subject is eligible; HCV RNA examination is required for HCV antibody positive subject, subject is eligible for enrollment if result was negative)
  • History of gastrointestinal perforation and /or fistula within 6 months before enrollment
  • Subjects with interstitial lung disease
  • Uncontrolled third space effusion, e.g. ascites or pleural effusion cannot be drained or controlled
  • Other primary malignancy, with the exception of:
  • Curable malignancy (e.g. papillary thyroid carcinoma)
  • Without active disease in the last 5 years and with very low recurrence risk
  • Non-melanoma skin cancer or malignant freckle-like nevus with adequate treatment and no evidence of recurrence ;
  • Adequately treated in-situ carcinoma
  • Women who are pregnant or in lactation period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer hospital Chinese academy of Medical sciences

    Beijing

Other trials in China

About this study

Official title: Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma: a Multicenter, Single Arm, Phase II Study

The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of patients with Relapsed/Refractory Hodgkin's Lymphoma.

Read the detailed description

Patients with classical Hodgkin lymphoma(cHL) who relapse after autologous stem-cell transplantation(ASCT) or progress after multiple lines of chemotherapy have a poor prognosis, with a median survival of approximately 1.2 years.

CHL frequently harbors a spectrum of chromosome 9p24.1/PD-L1/PD-L2 alterations, leading to overexpression of the programmed death 1 ligands,PD-L1 and PD-L2.

Sintilimab is a humanized monoclonal antibody against PD-1 that blocks the interaction between PD-1 and its ligands and was approved for relapsed/refractory Hodgkin lymphoma in China in 2018.

This study is a single arm,phase 2 study designed to evaluate the clinical activity of sintilimab in Chinese patients with R/R

Being tested
PD1
Keywords
Hodgkin Lymphoma
Medical subject headings
Recurrence, Hodgkin Disease

What participants receive

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

  • PD1Drug

    IBI308 200mg/3 weeks

Study groups in NCT03114683
Study groupRoleWhat they receive
IBI308ExperimentalNot described
Receives: Drug: PD1

What is being measured

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

  1. Objective Response Rate (ORR) Assessed According to the Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) by the Independent Radiological Review Committee (IRRC).

    Per Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) assessed by CT and PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥50% decrease in SPD of up to 6 largest dominant masses, no increase in size of other nodes; Overall Response (OR) = CR + PR

    Measured: Up to 2 years

Timeline

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

  1. First posted14 Apr 2017
  2. Study start30 Mar 2017
  3. Primary completion12 Sep 2019
  4. Study completion30 Nov 2019

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114683
Sponsor's protocol ID
CIBI308B201
Acronym
ORIENT-1
Status last verified
Nov 2020
First submitted
4 Apr 2017
Last updated
7 Dec 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Su H, Song Y, Jiang W, Sun X, Qian W, Zhang W, Gao Y, Jin Z, Zhou J, Jin C, Zou L, Qiu L, Li W, Yang J, Hou M, Zeng S, Zhang Q, Hu J, Zhou H, Xiong Y, Liu P. Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2019 Jan;6(1):e12-e19. doi: 10.1016/S2352-3026(18)30192-3.

    PubMed 30612710

  • Shi Y, Su H, Song Y, Jiang W, Sun X, Qian W, Zhang W, Gao Y, Jin Z, Zhou J, Jin C, Zou L, Qiu L, Li W, Yang J, Hou M, Xiong Y, Zhou H, Du X, Wang X, Peng B. Circulating tumor DNA predicts response in Chinese patients with relapsed or refractory classical hodgkin lymphoma treated with sintilimab. EBioMedicine. 2020 Apr;54:102731. doi: 10.1016/j.ebiom.2020.102731.

    PubMed 32304999

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD1 in people with Relapsed/Refractory Classical 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 13 inclusion and 37 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: finished, as of the sponsor's last update on 7 Dec 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?

Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Assessed According to the Revised International Working Group Response Criteria for Malignant Lymphoma in 2007(IWG 2007) by the Independent Radiological Review Committee (IRRC). (time frame: Up to 2 years). 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 NCT03114683, which also lists 2 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 7 Dec 2020.

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