- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05821192
Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.
April 7, 2023 updated by: Ou Bai, MD/PHD
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.
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Recruiting
- The First Bethune Hospital of Jilin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R-GDP plus PD-1 monoclonal antibody
Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
|
375mg/m2 by IV infusion once every 3 weeks
1 g/m2 on Days 1 by IV infusion once every 3 weeks
40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
75 mg/m2 on Days 1 by IV infusion once every 3 weeks
200mg on Days 2 by IV infusion once every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 16 months
|
Percentage of Complete remission (CR), and Partial remission (PR).
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 24 months
|
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.
|
24 months
|
Overall survival (OS)
Time Frame: 24 months
|
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
|
24 months
|
Incidence of adverse events (AEs)
Time Frame: 24 months
|
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
|
24 months
|
Serious Adverse Event (SAE)
Time Frame: 24 months
|
A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes:
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ou Bai, doctor, The First Hospital of Jilin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2023
Primary Completion (Anticipated)
April 18, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
March 23, 2023
First Submitted That Met QC Criteria
April 7, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphadenopathy
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Immunoblastic Lymphadenopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Gemcitabine
- Dexamethasone
- Antibodies
- Rituximab
- Antibodies, Monoclonal
Other Study ID Numbers
- rrPTCL-R-PD1-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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