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

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
• Conditions: Angioimmunoblastic T-cell Lymphoma; Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Intervention / Treatment: Drug: Rituximab; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin; Drug: PD-1 monoclonal antibody

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

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Bethune Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma confirmed by histopathology;
2. Age 18 to 70 years for all sexs;
3. 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;
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
5. Life expectancy ≥ 3 months;
6. 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.);

7. Function of organs:

   1. 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);
   2. 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;
   3. Renal function: Creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 30ml/min or creatinine clearance rate ≤ 2.5 times ULN;
   4. Pulmonary function: blood oxygen saturation ≥ 95% in resting state without oxygen inhalation;
   5. 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);
   6. Heart function: LVEF ≥ 50%;

Exclusion Criteria:

1. 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);
2. There is an active infection, including but not limited to known active tuberculosis, known latent tuberculosis, herpes zoster and pneumonia;

3. 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:

   1. 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;
   2. Patients with HCVAb (+) and HCV RNA < 15 IU/mL can be selected;
4. 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;
5. 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;
6. 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;
7. Patients have interstitial pneumonia or once had chemotherapy-induced interstitial pneumonia during chemotherapy, who have treatment risk in the estimation of investigator;
8. Pregnant or lactating women;
9. The investigator determine the patients having other infectors which may affect compliance;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R-GDP plus PD-1 monoclonal antibody; Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody	Drug: Rituximab; 375mg/m2 by IV infusion once every 3 weeks; Drug: Gemcitabine; 1 g/m2 on Days 1 by IV infusion once every 3 weeks; Drug: Dexamethasone; 40 mg on Days 1 to 4 of each 3-week cycle by IV infusion; Drug: Cisplatin; 75 mg/m2 on Days 1 by IV infusion once every 3 weeks; Drug: PD-1 monoclonal antibody; 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)	Percentage of Complete remission (CR), and Partial remission (PR).	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
Overall survival (OS)	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)	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)	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	24 months

Collaborators and Investigators

• Sponsor: Ou Bai, MD/PHD
• Collaborators: Second Hospital of Jilin University; China-Japan Union Hospital, Jilin University
• Investigators: Study Chair: Ou Bai, doctor, The First Hospital of Jilin University

Study record dates

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