Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.

NCT ID: NCT06563778

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2028-09-01

Brief Summary

The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.

Detailed Description

The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin or Bendamustine plus Anti-PD-1 Antibody are both standard regimens.The combination of Brentuximab Vedotin, Bendamustine and Anti-PD-1 Antibody may be another effective regimen. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody, in patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant .

The primary objective of the study is to evaluate the progression free survival. The key secondary end points are complete response rate, objective response rate and the safety.

Conditions

Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide+Decitabine+ Anti-PD-1 Antibody

Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. 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. Immune checkpoint inhibitors have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells.

Group Type: EXPERIMENTAL

Chidamide; Decitabine; Anti-PD-1 Antibody

Intervention Type: DRUG

Chidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Brentuximab Vedotin+ Bendamustine+anti-PD-1 antibody

Group Type: ACTIVE_COMPARATOR

Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody

Intervention Type: DRUG

Brentuximab Vedotin 1.2-1.8mg/kg day 1, Bendamustine 70-90mg/m2 day1-2, Anti-PD-1 antibody day 2. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Interventions

Chidamide; Decitabine; Anti-PD-1 Antibody

Chidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Intervention Type: DRUG

Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody

Brentuximab Vedotin 1.2-1.8mg/kg day 1, Bendamustine 70-90mg/m2 day1-2, Anti-PD-1 antibody day 2. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han weidong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Han W dong, Prfessor

Role: CONTACT

hanwdrsw@sina.com

01055499341

Facility Contacts

Han W Weidong, Prfessor

Role: primary

hanwdrsw@sina.com

86-10-13651392893

Other Identifiers

CHN-PLAGH-BT-089

Identifier Type: -

Identifier Source: org_study_id