Clinical trial · Interventional
PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Refractory or Relapsed Classical Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor | Drug | — | UNRESOLVED |
| PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Inhibitor or PD-1 Inhibitor with GVD
- description
- 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.
- interventionNames
- Drug: PD-1 inhibitor
- Drug: PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available