Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma
Conditions
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.
Interventions
DRUGRituximab
375mg/m2 by IV infusion once every 3 weeks
DRUGGemcitabine
1 g/m2 on Days 1 by IV infusion once every 3 weeks
DRUGDexamethasone
40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
DRUGCisplatin
75 mg/m2 on Days 1 by IV infusion once every 3 weeks
200mg on Days 2 by IV infusion once every 3 weeks
Sponsors
Second Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Ou Bai, MD/PHD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 16 months | Percentage of Complete remission (CR), and Partial remission (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Countries
China
Contacts
Primary ContactOu Bai, doctor
Outcome results
None listed