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| Name | Class |
|---|---|
| Second Hospital of Jilin University | OTHER |
| China-Japan Union Hospital, Jilin University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-GDP plus PD-1 monoclonal antibody | Experimental | Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375mg/m2 by IV infusion once every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Percentage of Complete remission (CR), and Partial remission (PR). | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 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. | 24 months |
| Overall survival (OS) |
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Inclusion Criteria:
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:
Exclusion Criteria:
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:
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou Bai, doctor | Contact | 13039046656 | oubai16@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ou Bai, doctor | The First Hospital of Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| Gemcitabine |
| Drug |
1 g/m2 on Days 1 by IV infusion once every 3 weeks |
|
| Dexamethasone | Drug | 40 mg on Days 1 to 4 of each 3-week cycle by IV infusion |
|
| Cisplatin | Drug | 75 mg/m2 on Days 1 by IV infusion once every 3 weeks |
|
| PD-1 monoclonal antibody | Drug | 200mg on Days 2 by IV infusion once every 3 weeks |
|
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
| 24 months |
| Incidence of adverse events (AEs) | Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. | 24 months |
| Serious Adverse Event (SAE) | A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes:
| 24 months |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D003907 | Dexamethasone |
| D002945 | Cisplatin |
| C000711728 | spartalizumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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