Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With RR NHL
NCT ID: NCT04134247
Last Updated: 2019-10-22
Study Results
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Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2019-11-01
2021-11-01
Brief Summary
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Detailed Description
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According to the characteristics of clinicopathology, lymphoma is divided into two categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). HL is a single disease, relatively rare, but the prognosis is good, and patients with limited period have no progress for 5 years. The survival rate was 85-95%, and the 5-year progression-free survival rate of advanced patients was 30-85%. NHL is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.
In recent years, immunological checkpoint inhibitors have been the focus of research in the field of malignant tumor treatment. In clinical trials, PD-1/PD-L1 was found to be abnormally expressed in various lymphomas, including T-cell lymphoma, mediastinal large B-cell lymphoma, classical Hodgkin's lymphoma (CHL), and large variability. Cell lymphoma. Previous studies have evaluated the effects of antibody-based drugs against PD-1 (such as navobizumab and pabuleizumab) in patients with relapsed or refractory classic Hodgkin's lymphoma, and A higher response rate is shown and the security feature is acceptable. The domestic ORIENT-1 study showed that ididilimumab was highly active in patients with relapsed or refractory classic Hodgkin's lymphoma in China, and 80% (74/92) patients had an objective response. No patients died during the study. Of the 96 patients treated, 89 (93%) had treatment-related adverse events, including 17 (18%) patients with grade 3 or 4 treatment-related adverse events, and 11 patients (11%) experienced severe Adverse events, but no unexpected or off-target safety signals were found. Therefore, PD1 antibodies may benefit patients with relapsed or refractory Hodgkin's lymphoma.
At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. Clinical studies at home and abroad have shown that PD-1 inhibitors are effective in relapsed or refractory extranodal NKT lymphoma. The results of the Idiliumab ORIENT-4 test showed that 1 year OS 82.1%, ORR 67.9%, DCR 85.7%, and PD-1 inhibitor combined with citabin to treat relapsed or refractory extranodal NKT is underway; PD-1 inhibitor monotherapy for relapsed or refractory PTCL is generally effective (ORR 33%, 4 of them CR); PD-1 inhibitor monotherapy is effective in treating relapsed or refractory mycosis/Sezary syndrome (ORR) 37.5%) has been recommended by the NCCN guidelines; trials in combination with IFN γ-1b are underway. PD-1 inhibitor monotherapy for relapsed or refractory PMBCL or PCNSL is effective, and PD-1 inhibitors have been recommended by the NCCN guidelines for the former treatment.
Therefore, we propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PD-1 combined with chemotherapy
21 days every cycle, assessment after 3-cycle
PD-1 combined with chemotherapy
PD-1 200 mg，d1; Rituximab 375mg/m2，d0（ the same as the chemotherapy group）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
chemotherapy
21 days every cycle, assessment after 3-cycle
chemotherapy
Rituximab 375mg/m2，d0（ Except for patients who relapsed within12 months after the last application of rituximab）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
Interventions
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PD-1 combined with chemotherapy
PD-1 200 mg，d1; Rituximab 375mg/m2，d0（ the same as the chemotherapy group）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
chemotherapy
Rituximab 375mg/m2，d0（ Except for patients who relapsed within12 months after the last application of rituximab）
The chemotherapy chooses one of the following:
GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A recurrent or refractory disease defined as: 1) recurrence of disease after complete remission (CR); or 2) partial remission (PR), disease stabilization (SD), or disease Progress (PD) when the treatment is completed prior to enrollment in the study.
3. Age≥18 years old, both men and women.
4. The ECOG score is 0-2.
5. There is at least one evaluable lesion (maximum diameter\>15mm or shortest diameter\>10mm). Preferably, PET-CT shows high metabolism of FDG.
6. Have received appropriate first-line and more-line treatment of the corresponding NHL.
7. Liver and kidney function: blood bilirubin≤35μmol/L, AST or ALT is less than 2 times the upper limit of normal value, serum creatinine≤150μmol/L.
8. The thyroid function is normal.
9. Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment.
10. Subjects must sign an informed consent form.
Exclusion Criteria
2. Received ASCT within 90 days prior to the first use of the study drug;
3. Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;
4. Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;
5. Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4
6. Exposure to any study drug within 4 weeks prior to the first use of the study drug
7. Expose to the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy or arterial embolization) within 3 weeks prior to the first use of the study drug.
8. Have a history of oncology and have received any treatment for this tumor in the past 3 years;
9. Patients during pregnancy and lactation;
10. Accompanied by severe heart disease, including acute myocardial infarction within 6 months, or in accordance with New York Heart Association cardiac function III or IV;
11. A serological test for HIV or active hepatitis C virus is known to be positive;
12. Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known;
13. TB patients active period
14. Other circumstances that the investigator believes are not suitable for inclusion.
18 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Wang Xin
Director of Department of Hematology
Principal Investigators
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Wang Xin, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Locations
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Department of Hematology, Shandong Provincial Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShandongPH006
Identifier Type: -
Identifier Source: org_study_id
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