Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With RR NHL

NCT04134247 | Unknown Phase 4

• 1 other identifier: ShandongPH006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (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.The anti-PD-1 antibody 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. 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

Relapsed/Refractory Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Percentage of patients with complete remission （CR）or partial remission （PR）

  2 years

Secondary Outcomes (2)

• Progression free survival（PFS）

  2 years

• overall survival（OS）

  2 years

Study Arms (2)

PD-1 combined with chemotherapy

EXPERIMENTAL

21 days every cycle, assessment after 3-cycle

Drug: PD-1 combined with chemotherapy

chemotherapy

ACTIVE COMPARATOR

21 days every cycle, assessment after 3-cycle

Drug: chemotherapy

Interventions

PD-1 combined with chemotherapy DRUG

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

Also known as: PD-1 combined with chemotherapy group

PD-1 combined with chemotherapy

chemotherapy DRUG

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

Also known as: chemotherapy group

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression.
• 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.
• Age≥18 years old, both men and women.
• The ECOG score is 0-2.
• There is at least one evaluable lesion (maximum diameter\>15mm or shortest diameter\>10mm). Preferably, PET-CT shows high metabolism of FDG.
• Have received appropriate first-line and more-line treatment of the corresponding NHL.
• 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.
• The thyroid function is normal.
• Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment.
• Subjects must sign an informed consent form.

You may not qualify if:

• Age\<18 years old；
• Received ASCT within 90 days prior to the first use of the study drug;
• Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;
• Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;
• Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4
• Exposure to any study drug within 4 weeks prior to the first use of the study drug
• 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.
• Have a history of oncology and have received any treatment for this tumor in the past 3 years;
• Patients during pregnancy and lactation;
• 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;
• A serological test for HIV or active hepatitis C virus is known to be positive;
• Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known;
• TB patients active period

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Department of Hematology, Shandong Provincial Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wang Xin, MD,PhD

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Xin, MD,PhD

CONTACT

+86-531-68778331; xinw8331@163.com

Ge Xueling, MD

CONTACT

+86-531-68778331; xueling0617@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Hematology

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)