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

NCT05821192 | Unknown

• 1 other identifier: rrPTCL-R-PD1-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Percentage of Complete remission (CR), and Partial remission (PR).

  16 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

• Incidence of adverse events (AEs)

  24 months

• Serious Adverse Event (SAE)

  24 months

Study Arms (1)

R-GDP plus PD-1 monoclonal antibody

EXPERIMENTAL

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

Drug: Rituximab; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin; Drug: PD-1 monoclonal antibody

Interventions

Rituximab DRUG

375mg/m2 by IV infusion once every 3 weeks

R-GDP plus PD-1 monoclonal antibody

Gemcitabine DRUG

1 g/m2 on Days 1 by IV infusion once every 3 weeks

R-GDP plus PD-1 monoclonal antibody

Dexamethasone DRUG

40 mg on Days 1 to 4 of each 3-week cycle by IV infusion

R-GDP plus PD-1 monoclonal antibody

Cisplatin DRUG

75 mg/m2 on Days 1 by IV infusion once every 3 weeks

R-GDP plus PD-1 monoclonal antibody

PD-1 monoclonal antibody DRUG

200mg on Days 2 by IV infusion once every 3 weeks

R-GDP plus PD-1 monoclonal antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ou Bai, MD/PHD: lead
• Second Hospital of Jilin University: collaborator
• China-Japan Union Hospital, Jilin University: collaborator

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Immunoblastic Lymphadenopathy

Interventions

Rituximab; Gemcitabine; Dexamethasone; Cisplatin; spartalizumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ou Bai, doctor

  The First Hospital of Jilin University

  STUDY CHAIR

Central Study Contacts

Ou Bai, doctor

CONTACT

13039046656; oubai16@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 20, 2023
• Study Start: March 23, 2023
• Primary Completion: April 18, 2023
• Study Completion: December 31, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)