UnknownPhase 2

Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL

China83 participantsStarted 2021-04-15

Plain-language summary

Angioimmunoblastic T-cell lymphoma (AITL) belongs to a subtype of peripheral T-cell lymphoma (PTCL) and is also a distinct type of non-Hodgkin lymphoma (NHL). The clinical outcomes of AITL is poor and optimal treatment strategies for AITL have not been fully defined. Patients with disseminated or relapsed disease have a very poor outcome, and there is no standard management for relapsed or refractory disease. Epigenetic drugs have been widely used to treat patients with refractory/relapse AITL. Several phase II clinical trails demonstrated the ORR of 33-50% in patients with r/r AITL treated with HDAC inhibitors (including Belimastat, Romidepsin, Chidamide). HDAC inhibitors are important drugs for the current treatment of AITL, but still more than half of the patients can not benefit from it. PD1/PD-L1 blockade was a potent strategy for r/r PTCL in two small sample studies. Current studies have found that HDACi can upregulate the expression of PDL1, In vivo testing of C57BL/6 mice revealed a synergistic tumor suppression after combining HDACi and PD-1 blockade. We carried out a single, open-label, multicenter clinical trial enrolled patients with relapsed/refractory AITL to investigate the safety and efficacy of sintilimab in combination with chidamide.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
✓. Aged 18-75 years old male or female;
✓. Angioimmunoblastic T-cell lymphoma confirmed by histopathology examination;
✓. Paraffin tissue specimens or fresh puncture tissue specimens are available;
✓. Patients with refractory or relapsed angioimmunoblastic T-cell lymphoma after anthracycline-contained regimen treatment. Refractory is defined as: patients did not get partial remission (PR) or better responses after first line treatment or disease progression within 6 months of the last protocol;
✓. Eastern cooperative oncology group score: 0-1;
✓. Estimated survival ≥ 3 months;
✓. There must be at least one evaluate able or measurable lesion that meets the RECIL 2017 Lymphoma criteria \[evaluable lesion: 18Ffluorodeoxyglucose/ Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions \> 15mm or extranodal lesions \> 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;

What they're measuring

Objective response rate (ORR), complete response rate (CRR), partial response rate (PRR)

Timeframe: Up to 24 months

Trial details

NCT IDNCT04831710

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-15

View on ClinicalTrials.gov More Angioimmunoblastic T-cell Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
✓. Aged 18-75 years old male or female;
✓. Angioimmunoblastic T-cell lymphoma confirmed by histopathology examination;
✓. Paraffin tissue specimens or fresh puncture tissue specimens are available;
✓. Patients with refractory or relapsed angioimmunoblastic T-cell lymphoma after anthracycline-contained regimen treatment. Refractory is defined as: patients did not get partial remission (PR) or better responses after first line treatment or disease progression within 6 months of the last protocol;
✓. Eastern cooperative oncology group score: 0-1;
✓. Estimated survival ≥ 3 months;
✓. There must be at least one evaluate able or measurable lesion that meets the RECIL 2017 Lymphoma criteria \[evaluable lesion: 18Ffluorodeoxyglucose/ Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions \> 15mm or extranodal lesions \> 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;

Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria