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

Classical Hodgkin Lymphoma Clinical Trial

Official title:

PD-1 Inhibitor or PD-1 Inhibitor Plus GVD(Gemcitabine, Vinorelbine and Doxorubicin Liposome) Regimen for Relapsed/Refractory Classical Hodgkin Lymphoma (R/R CHL): a Single Arm, Open Label, Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624984
• Other study ID #: B2020-238-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 2025

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Qingqing Cai, MD
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma
• Refractory or Relapsed Classical Hodgkin Lymphoma

Intervention

Drug:
• PD-1 inhibitor
PD-1 Inhibitor, intravenous drip, d1.
• 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;

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.	2 years
Secondary	Objective Response rate	Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.	2 years
Secondary	Progression Free Survival	The time from the start of treatment to the progression of the tumor or death (due to any cause).	5 years
Secondary	Overall Survival	The time from the start of treatment to time of death (due to any cause).	5 years
Secondary	Duration of Response	The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).	5 years
Secondary	Time to Response (TTR)	The time from the start of treatment to the first assessment of complete remission or partial remission.	2 years
Secondary	Percentage of Participants With Adverse Events	Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0	2 years