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

NCT ID: NCT05821192

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-GDP plus PD-1 monoclonal antibody

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

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

375mg/m2 by IV infusion once every 3 weeks

Gemcitabine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

PD-1 monoclonal antibody

Intervention Type: DRUG

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

Interventions

Rituximab

375mg/m2 by IV infusion once every 3 weeks

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

PD-1 monoclonal antibody

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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role: collaborator

Ou Bai, MD/PHD

OTHER

Sponsor Role: lead

Responsible Party

Ou Bai, MD/PHD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ou Bai, doctor

Role: STUDY_CHAIR

The First Hospital of Jilin University

Locations

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ou Bai, doctor

Role: CONTACT

oubai16@163.com

13039046656

Facility Contacts

Ou BAI, doctor

Role: primary

oubai16@163.com

13039046656

Other Identifiers

rrPTCL-R-PD1-001

Identifier Type: -

Identifier Source: org_study_id