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

Primary Purpose

Classical Hodgkin Lymphoma, Refractory or Relapsed Classical Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 inhibitor
PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Recruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 Inhibitor or PD-1 Inhibitor with GVD

Arm 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.

Outcomes

Primary Outcome Measures

Complete remission rate
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

Secondary Outcome Measures

Objective Response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Progression Free Survival
The time from the start of treatment to the progression of the tumor or death (due to any cause).
Overall Survival
The time from the start of treatment to time of death (due to any cause).
Duration of Response
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Time to Response (TTR)
The time from the start of treatment to the first assessment of complete remission or partial remission.
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

Full Information

First Posted
November 6, 2020
Last Updated
May 6, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04624984
Brief Title
PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma, Refractory or Relapsed Classical Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1 Inhibitor or PD-1 Inhibitor with GVD
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor
Intervention Description
PD-1 Inhibitor, intravenous drip, d1.
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome
Intervention Description
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;
Primary Outcome Measure Information:
Title
Complete remission rate
Description
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective Response rate
Description
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time Frame
2 years
Title
Progression Free Survival
Description
The time from the start of treatment to the progression of the tumor or death (due to any cause).
Time Frame
5 years
Title
Overall Survival
Description
The time from the start of treatment to time of death (due to any cause).
Time Frame
5 years
Title
Duration of Response
Description
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Time Frame
5 years
Title
Time to Response (TTR)
Description
The time from the start of treatment to the first assessment of complete remission or partial remission.
Time Frame
2 years
Title
Percentage of Participants With Adverse Events
Description
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yudan Wu, MD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, MD
Facility Name
The First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyi Pan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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