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

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

NCT ID: NCT05821192

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

Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Dexamethasone
Rituximab
Gemcitabine
Antibodies
Antibodies, Monoclonal

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rituximab
Description: 375mg/m2 by IV infusion once every 3 weeks
Arm group label: R-GDP plus PD-1 monoclonal antibody

Intervention type: Drug
Intervention name: Gemcitabine
Description: 1 g/m2 on Days 1 by IV infusion once every 3 weeks
Arm group label: R-GDP plus PD-1 monoclonal antibody

Intervention type: Drug
Intervention name: Dexamethasone
Description: 40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
Arm group label: R-GDP plus PD-1 monoclonal antibody

Intervention type: Drug
Intervention name: Cisplatin
Description: 75 mg/m2 on Days 1 by IV infusion once every 3 weeks
Arm group label: R-GDP plus PD-1 monoclonal antibody

Intervention type: Drug
Intervention name: PD-1 monoclonal antibody
Description: 200mg on Days 2 by IV infusion once every 3 weeks
Arm group label: R-GDP plus PD-1 monoclonal antibody

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.

Criteria for eligibility:
Criteria:
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;

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Bethune Hospital of Jilin University

Address:
City: Changchun
Zip: 130021
Country: China

Status: Recruiting

Contact:
Last name: Ou BAI, doctor

Phone: 13039046656
Email: oubai16@163.com

Start date: March 23, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Ou Bai, MD/PHD
Agency class: Other

Collaborator:
Agency: Second Hospital of Jilin University
Agency class: Other

Collaborator:
Agency: China-Japan Union Hospital, Jilin University
Agency class: Other

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05821192