A Prospective Study of PD-1 Inhibitor Combined With ICE in the Treatment of Relapsed/Refractory Gray Area Lymphoma

NCT04860674 | Unknown Phase 2

• 1 other identifier: PICE
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are no standard chemotherapy regimens for relapse/refractory gray area lymphoma. The programmed cell death ligand 1 (PD-L1) encoding gene is located in 9p24.1, so it is speculated that the programmed cell death pathway plays an important role in gray area lymphoma formation by evading immune surveillance in GZL.The purpose of this study was to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with ICE in the treatment of patients with relapsed/refractory gray area lymphoma.

Conditions

Gray Zone Lymphoma; Relapse/Recurrence; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  From enrollment until date of completion of chemotherapy, at the end of cycle 6 (each cycle is 21 days)

Secondary Outcomes (3)

• PFS

  From date of first day of treatment until the date of first documented progression, assessed up to 24 months

• OS

  From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months

• AE and SAE

  From data of first day of treatment until 30 day after last treatment

Study Arms (1)

PD-1+ICE

EXPERIMENTAL

PD-1 inhibitor combined with icyclophosphamide, carboplatin, etoposide chemotherapy

Drug: PD-1 inhibitor +ICE

Interventions

PD-1 inhibitor +ICE DRUG

PD-1 inhibitor (tirelizumab) combined with ifosfamide, carboplatin and etoposide (ICE) regimen

Also known as: Icyclophosphamide, carboplatin, etoposide

PD-1+ICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in the clinical study: fully understand and know the study and sign the informed consent form in person;Willing to follow and able to complete all testing procedures.
• Age: 18\~70 years old (inclusive), both male and female.
• Histopathologically confirmed gray zone lymphoma (between HD and DLBCL).
• Recurrent or refractory disease after receiving at least first-line standard chemotherapy (refractory is defined as chemotherapy not reaching CR or PR).
• ECOG score is 0-2 points.
• Expected survival of at least 3 months.
• There must be at least one evaluable or measurable lesion that meets the Lugano2014 criteria.
• Sufficient organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency
• Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
• Serum pregnancy test was negative and effective contraceptive measures were taken from the signing of informed consent until 6 months after the use of the last chemotherapy.
• Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within the range of ±10% of normal values.
• There was no evidence that subjects had difficulty breathing at rest and their pulse oximetry at rest was \>95%.
• Subjects must confirm the first forced expiratory volume (FEV1)/forced expiratory volume (FVC) \>60% by pulmonary function test, unless large mediastinal mass compression fails to meet this standard;Carbon monoxide dispersion (DLCO), FEV1 and FVC all exceeded the predicted value by more than 50%.

You may not qualify if:

• Central nervous system involvement.
• Participating in other clinical studies, or administering the first study drug less than 4 weeks after the end of treatment in the previous clinical study.
• Had other malignant tumors in the past 5 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix after radical treatment.
• The last antitumor treatment was less than 3 weeks after the first administration of the drug in this study, including chemotherapy, immunotherapy, radiotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors for cancer control).
• Previous allogeneic hematopoietic stem cell transplantation or prior ASCT or CAR-T therapy within 1 month prior to initial dosing of the investigational drug.
• Have previously received PD-1 or PD-L1 targeted therapy.
• A history of severe hypersensitivity to monoclonal antibodies.
• Major surgery was performed within 28 days prior to the start of study treatment.
• In this study, the patients received anti-tumor Chinese herbal medicine or proprietary Chinese medicine within 7 days before the first medication.
• Live vaccine (except attenuated influenza vaccine) was administered within 28 days before the first administration.
• Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome.
• Patients with active history of autoimmune disease or blood body autoimmune disease and patients with high risk of recurrence, including but not limited to the immune related neuropathy, multiple sclerosis, autoimmune, demyelinating neuropathy, GBS, myasthenia gravis, systemic lupus erythematosus (sle), scleroderma, connective tissue disease, inflammatory bowel cancer (including crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrosis release or Stevens Johnson syndrome.
• Corticosteroid (prednisone \>10mg/d or equivalent) or other immunosuppressive systemic therapy should be used within 14 days prior to the first administration of the study drug.
• Patients with active chronic hepatitis B or active hepatitis C.
• Have active tuberculosis.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Recurrence

Interventions

Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Cong Li

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cong Li

CONTACT

15267115611; licong@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share