PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL
Phase 2
Recruiting
- Conditions
- Refractory or Relapsed Classical Hodgkin LymphomaClassical Hodgkin Lymphoma
- Interventions
- Drug: PD-1 inhibitor
- Registration Number
- NCT04624984
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD-1 Inhibitor or PD-1 Inhibitor with GVD PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome 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. PD-1 Inhibitor or PD-1 Inhibitor with GVD PD-1 inhibitor 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.
- Primary Outcome Measures
Name Time Method Complete remission rate 2 years Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
- Secondary Outcome Measures
Name Time Method Progression Free Survival 5 years The time from the start of treatment to the progression of the tumor or death (due to any cause).
Percentage of Participants With Adverse Events 2 years Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Objective Response rate 2 years Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time to Response (TTR) 2 years The time from the start of treatment to the first assessment of complete remission or partial remission.
Overall Survival 5 years The time from the start of treatment to time of death (due to any cause).
Duration of Response 5 years The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Trial Locations
- Locations (3)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China