NCT03114683

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

April 4, 2017

Results QC Date

October 12, 2020

Last Update Submit

November 12, 2020

Conditions

Relapsed/Refractory Classical Hodgkin's Lymphoma

Keywords

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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

    Up to 2 years

Study Arms (1)

IBI308

EXPERIMENTAL
Drug: PD1

Interventions

PD1DRUG

IBI308 200mg/3 weeks

IBI308

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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.
  • 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.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital Chinese academy of Medical sciences

Beijing, China

Location

Related Publications (2)

  • 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.

    PMID: 30612710BACKGROUND

  • 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.

    PMID: 32304999BACKGROUND

Related Links

MeSH Terms

Conditions

RecurrenceHodgkin Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Yi Bo
Organization
Innovent Biologics (Suzhou) Co., Ltd. (seal)
jessica.yi@innoventbio.com
+8613382419112

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 14, 2017

Study Start

March 30, 2017

Primary Completion

September 12, 2019

Study Completion

November 30, 2019

Last Updated

December 7, 2020

Results First Posted

December 7, 2020

Record last verified: 2020-11

Locations

CN(1)