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

Phase 2

Recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: SHR-1210; Drug: Decitabine

• Registration Number: NCT03250962
• Lead Sponsor: Chinese PLA General Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Study Start: 2017-09-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01
• Primary Completion: 2022-07-21
• Study Completion: 2025-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1210-plus-Decitabine	SHR-1210	Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
SHR-1210	SHR-1210	SHR-1210 200 mg, day 1, every 3 weeks.
SHR-1210-plus-Decitabine	Decitabine	Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.

Primary Outcome Measures

Name	Time	Method
stage II: duration of CR	5 years	Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
stage I: Number of Subjects with treatment-related adverse events (AEs)	2 years	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
stage I: CRR assess by investigators per the 2014 Lugano classification	3 years	rate of subjects achieved complete response in all evaluable subjects

Secondary Outcome Measures

Name	Time	Method
stage II: duration of response	5 years	Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
stage II: Progression free survival	5 years	Time measured from the day of treatment to the date of first documented progression, or death from any cause.

Trial Locations

Locations (1)

Biotherapeutic Department of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China