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

Not Applicable

Recruiting

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

• Registration Number: NCT05821192
• Lead Sponsor: Ou Bai, MD/PHD

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.

Study Timeline

• Study Start: 2023-03-23
• Study First Submitted: 2023-03-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Primary Completion: 2023-04-18
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-GDP plus PD-1 monoclonal antibody	PD-1 monoclonal antibody	Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
R-GDP plus PD-1 monoclonal antibody	Gemcitabine	Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
R-GDP plus PD-1 monoclonal antibody	Dexamethasone	Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
R-GDP plus PD-1 monoclonal antibody	Rituximab	Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody
R-GDP plus PD-1 monoclonal antibody	Cisplatin	Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	16 months	Percentage of Complete remission (CR), and Partial remission (PR).

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	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.
Progression-free survival (PFS)	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.
Overall survival (OS)	24 months	Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
Serious Adverse Event (SAE)	24 months	A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes: 1. is fatal, is life-threatening; 2. requires or prolongs inpatient hospitalization; 3. results in persistent or significant disability/incapacity; 4. constitutes a congenital anomaly or birth defect

Trial Locations

Locations (1)

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China