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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2025
  • participants needed
    42
  • sponsor
    Sun Yat-sen University
Updated on 26 April 2021

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.

Details
Condition Classical Hodgkin Lymphoma, Refractory or Relapsed Classical Hodgkin Lymphoma
Treatment PD-1 Inhibitor, PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome
Clinical Study IdentifierNCT04624984
SponsorSun Yat-sen University
Last Modified on26 April 2021

Eligibility

Yes No Not Sure

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 (>1.510^9/L); 2) platelet count (> 7510^9/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
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