Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03250962
Other study ID # CHN-PLAGH-BT-023
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 11, 2017
Est. completion date March 21, 2025

Study information

Verified date March 2019
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 280
Est. completion date March 21, 2025
Est. primary completion date July 21, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Biotherapeutic Department of Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Primary stage I: CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects 3 years
Primary 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. 5 years
Secondary 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. 5 years
Secondary stage II: Progression free survival Time measured from the day of treatment to the date of first documented progression, or death from any cause. 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Active, not recruiting NCT03617666 - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting NCT02507479 - Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies Phase 2
Active, not recruiting NCT02191930 - Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma Phase 2
Completed NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT01393106 - Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma Phase 2
Terminated NCT00992030 - R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma Phase 3
Terminated NCT00722865 - Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma Phase 2
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Active, not recruiting NCT05205512 - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial N/A
Recruiting NCT03681561 - Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT04510610 - Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Phase 2/Phase 3
Completed NCT06295211 - Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
Active, not recruiting NCT02256137 - A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Completed NCT02432235 - Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma Phase 1
Completed NCT02572167 - A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma Phase 1/Phase 2