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Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

Primary Purpose

Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rituximab
Gemcitabine
Dexamethasone
Cisplatin
PD-1 monoclonal antibody
Sponsored by
Ou Bai, MD/PHD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma confirmed by histopathology; Age 18 to 70 years for all sexs; Progressive disease or no response in patients who have received first-line chemotherapy (at least 2 cycles), and patients who refuse or can't suffer from intravenous chemotherapy; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Life expectancy ≥ 3 months; There are measurable lesions (lymph nodes enlargement, nodal masses, enlargement of lymphoid organs and extranodal lesion that are measurable in two diameters (longest diameter and shortest diameter). A measurable node must have an longest diameter greater than 1.5 cm. A measurable extranodal lesion should have an longest diameter greater than 1.0 cm.); Function of organs: Hepatic function: Total bilirubin ≤ 1.5 times upper limit of normal (ULN), direct bilirubin ≤ 1.5 times ULN; aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma); Bone marrow function (without growth factor in 7 days before the first drugs): WBC ≥ 2.0×109/l; ANC ≥ 1.0×109/l; PLT ≥ 50×109/l; Hb ≥ 8g/dl; Renal function: Creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 30ml/min or creatinine clearance rate ≤ 2.5 times ULN; Pulmonary function: blood oxygen saturation ≥ 95% in resting state without oxygen inhalation; Coagulation function: international normalised ratio (INR) ≤ 1.5 times ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN (Patients whose prolonged PT or increased INR resulted in clotting factor inhibitors, should be selected at the investigator's discretion); Heart function: LVEF ≥ 50%; Exclusion Criteria: Unrelieved toxic reaction CTCAE grade > 1 before the first drugs in this research (except adverse effects that won't affect this study, estimated by the investigator, such as alopecia); There is an active infection, including but not limited to known active tuberculosis, known latent tuberculosis, herpes zoster and pneumonia; Patient is known to be positive for Human immunodeficiency virus (HIV) infection; Or serological status reflect active hepatitis B virus(HBV) infection or active hepatitis C virus (HCV) infection: Patients with HBsAg(+), HBcAb (+) or HBsAg (+) should detect HBV-DNA. Patients who has HBV-DNA ≤ 1000IU/ml and agree to have anti-HBV therapy can be selected; Patients with HCVAb (+) and HCV RNA < 15 IU/mL can be selected; Heart failure with New York Heart Association (NYHA) grade III or IV, unstable angina pectoris, severe ventricular arrhythmias with poor control, acute myocardial ischemia showed by electrocardiogram or had myocardial infarction in 6 months before screening. Or patients can't suffer from chemotherapy due to other heart function disorders, estimated by investigator; Intractable nausea or vomiting that can't be controlled by supportive care, chronic gastrointestinal diseases or dysphagia of capsules, or had intestinal resection which may affect the drug absorption; The investigator determined or other evidence showed patients have severe or poorly controlled systemic diseases, including poorly controlled hypertension and active bleeding body constitution. Patients with thrombotic diseases such as pulmonary embolism and deep venous thrombosis are also not suitable to participate in this study; Patients have interstitial pneumonia or once had chemotherapy-induced interstitial pneumonia during chemotherapy, who have treatment risk in the estimation of investigator; Pregnant or lactating women; The investigator determine the patients having other infectors which may affect compliance;

Sites / Locations

  • The First Bethune Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-GDP plus PD-1 monoclonal antibody

Arm Description

Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Percentage of Complete remission (CR), and Partial remission (PR).

Secondary Outcome Measures

Progression-free survival (PFS)
Progression-free survival#PFS# is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.
Overall survival (OS)
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Serious Adverse Event (SAE)
A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes: is fatal, is life-threatening requires or prolongs inpatient hospitalization results in persistent or significant disability/incapacity constitutes a congenital anomaly or birth defect

Full Information

First Posted
March 23, 2023
Last Updated
April 7, 2023
Sponsor
Ou Bai, MD/PHD
Collaborators
Second Hospital of Jilin University, China-Japan Union Hospital, Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT05821192
Brief Title
Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.
Official Title
A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
April 18, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ou Bai, MD/PHD
Collaborators
Second Hospital of Jilin University, China-Japan Union Hospital, Jilin 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
A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy.
Detailed Description
Objective to evaluate the efficacy and safety of R-GDP (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) plus PD-1 monoclonal antibody in patients with refractory or relapsed peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R-GDP plus PD-1 monoclonal antibody
Arm Type
Experimental
Arm Description
Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375mg/m2 by IV infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1 g/m2 on Days 1 by IV infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2 on Days 1 by IV infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
PD-1 monoclonal antibody
Intervention Description
200mg on Days 2 by IV infusion once every 3 weeks
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Percentage of Complete remission (CR), and Partial remission (PR).
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival#PFS# is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.
Time Frame
24 months
Title
Overall survival (OS)
Description
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
Time Frame
24 months
Title
Incidence of adverse events (AEs)
Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time Frame
24 months
Title
Serious Adverse Event (SAE)
Description
A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes: is fatal, is life-threatening requires or prolongs inpatient hospitalization results in persistent or significant disability/incapacity constitutes a congenital anomaly or birth defect
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma confirmed by histopathology; Age 18 to 70 years for all sexs; Progressive disease or no response in patients who have received first-line chemotherapy (at least 2 cycles), and patients who refuse or can't suffer from intravenous chemotherapy; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Life expectancy ≥ 3 months; There are measurable lesions (lymph nodes enlargement, nodal masses, enlargement of lymphoid organs and extranodal lesion that are measurable in two diameters (longest diameter and shortest diameter). A measurable node must have an longest diameter greater than 1.5 cm. A measurable extranodal lesion should have an longest diameter greater than 1.0 cm.); Function of organs: Hepatic function: Total bilirubin ≤ 1.5 times upper limit of normal (ULN), direct bilirubin ≤ 1.5 times ULN; aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma); Bone marrow function (without growth factor in 7 days before the first drugs): WBC ≥ 2.0×109/l; ANC ≥ 1.0×109/l; PLT ≥ 50×109/l; Hb ≥ 8g/dl; Renal function: Creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 30ml/min or creatinine clearance rate ≤ 2.5 times ULN; Pulmonary function: blood oxygen saturation ≥ 95% in resting state without oxygen inhalation; Coagulation function: international normalised ratio (INR) ≤ 1.5 times ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN (Patients whose prolonged PT or increased INR resulted in clotting factor inhibitors, should be selected at the investigator's discretion); Heart function: LVEF ≥ 50%; Exclusion Criteria: Unrelieved toxic reaction CTCAE grade > 1 before the first drugs in this research (except adverse effects that won't affect this study, estimated by the investigator, such as alopecia); There is an active infection, including but not limited to known active tuberculosis, known latent tuberculosis, herpes zoster and pneumonia; Patient is known to be positive for Human immunodeficiency virus (HIV) infection; Or serological status reflect active hepatitis B virus(HBV) infection or active hepatitis C virus (HCV) infection: Patients with HBsAg(+), HBcAb (+) or HBsAg (+) should detect HBV-DNA. Patients who has HBV-DNA ≤ 1000IU/ml and agree to have anti-HBV therapy can be selected; Patients with HCVAb (+) and HCV RNA < 15 IU/mL can be selected; Heart failure with New York Heart Association (NYHA) grade III or IV, unstable angina pectoris, severe ventricular arrhythmias with poor control, acute myocardial ischemia showed by electrocardiogram or had myocardial infarction in 6 months before screening. Or patients can't suffer from chemotherapy due to other heart function disorders, estimated by investigator; Intractable nausea or vomiting that can't be controlled by supportive care, chronic gastrointestinal diseases or dysphagia of capsules, or had intestinal resection which may affect the drug absorption; The investigator determined or other evidence showed patients have severe or poorly controlled systemic diseases, including poorly controlled hypertension and active bleeding body constitution. Patients with thrombotic diseases such as pulmonary embolism and deep venous thrombosis are also not suitable to participate in this study; Patients have interstitial pneumonia or once had chemotherapy-induced interstitial pneumonia during chemotherapy, who have treatment risk in the estimation of investigator; Pregnant or lactating women; The investigator determine the patients having other infectors which may affect compliance;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ou Bai, doctor
Phone
13039046656
Email
oubai16@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ou Bai, doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

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