PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL

NCT ID: NCT04624984

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-04-30

Brief Summary

This phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy.

Conditions

Classical Hodgkin Lymphoma; Refractory or Relapsed Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 Inhibitor or PD-1 Inhibitor with GVD

All patients receive PD-1 Inhibitor on day 1. Treatment cycles repeat every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR or PR receive PD-1 Inhibitor for another 3 cycles. Patients with PD or SD receive PD-1 Inhibitor plus GVD (gemcitabine, vinorelbine and doxorubicin liposome) regimen every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Patients with PET/CT confirmed CR after 6 cycles of PD-1 Inhibitor treatment can receive radiotherapy or ASCT, which is determined by investigators. Patients with PR receive 2-4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with PD or SD receive 4 cycles of PD-1 Inhibitor plus GVD regimen.

Patients with confirmed CR or PR after PD-1 Inhibitor plus GVD regimen can receive radiotherapy or ASCT, which is determined by investigators. Patients with PD or SD quit the trial.

Group Type: EXPERIMENTAL

PD-1 inhibitor

Intervention Type: DRUG

PD-1 Inhibitor, intravenous drip, d1.

PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome

Intervention Type: DRUG

PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1;

Interventions

PD-1 inhibitor

PD-1 Inhibitor, intravenous drip, d1.

Intervention Type: DRUG

PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome

PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed classical Hodgkin lymphoma;
• Refractory to or relapsed after first-line induction therapy; prior radiotherapy is allowed;
• At least one evaluable lesion according to 2014 Lugano criteria;
• Life expectancy > 3 months;
• Eastern Cooperative Oncology Group (ECOG) of 0-1;
• Able to participate in all required study procedures;
• Proper functioning of the major organs: 1) The absolute value of neutrophils (>1.5×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 80 g/L); 4) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) < 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time). ; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (±10%);
• There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%;
• Volunteers who signed informed consent.

Exclusion Criteria

• Involvement of central nervous system (CNS);
• Previously received treatment of immune checkpoint inhibitors (eg. PD-1, PD-L1, CTLA-4);
• Previously received treatment of hematopoietic cell transplantation;
• Patients with Hemophagocytic syndrome;
• Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
• Requiring treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens).
• Uncontrolled active infection, with the exception of tumor-related B symptom fever;
• History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
• Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 10^4 copies/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 10^4 copies/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
• Diagnosed with or receiving treatment for malignancy other than lymphoma;
• Pregnant or breastfeeding women;
• Other researchers consider it unsuitable for patients to participate in this study.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingqing Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Guangzhou, Guangdong, China

Site Status: RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqing Cai, MD

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Facility Contacts

Yudan Wu, MD

Role: primary

Qingqing Cai, MD

Role: primary

Xueyi Pan, MD

Role: primary

Other Identifiers

B2020-238-01

Identifier Type: -

Identifier Source: org_study_id