Classical Hodgkin Lymphoma, Refractory or Relapsed Classical Hodgkin Lymphoma
Conditions
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.
Interventions
DRUGPD-1 inhibitor
PD-1 Inhibitor, intravenous drip, d1.
DRUGPD-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;
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate | 2 years | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 5 years | The time from the start of treatment to the progression of the tumor or death (due to any cause). |
| Overall Survival | 5 years | The time from the start of treatment to time of death (due to any cause). |
| 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. |
| 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 |
| 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). |
Countries
China
Contacts
Primary ContactQingqing Cai, MD
Outcome results
None listed