A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT

NCT04843267 | Unknown Phase 2

• 1 other identifier: B2020-324-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The experimental drug regimen in this study includes a PD-1 antibody (tislelizumab) single-drug induction treatment period and a PD-1 antibody + AVD combined treatment period.

1. 1.PD-1 antibody (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for CR patients):
2. 2.PET/CT mid-term efficacy evaluation used for guiding follow-up treatment options:
3. 3.PD-1 antibody + AVD combined treatment period (3rd-6th/8th course for PR patients):

Conditions

Hodgkin Lymphoma; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• complete response rate after two cycles of tislelizumab

  complete response rate after two cycles of tislelizumab by PET/CT

  6 weeks

Interventions

Tislelizumab DRUG

Tislelizumab in first-line treatment of Hodgkin's lymphoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology;
• Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)
• Patients not suitable for receiving radiotherapy subsequently
• Patients with at least one assessable lesion (according to Lugano 2014 standard);
• Age 18 or above (including 18), no gender requirement;
• ECOG PS score of 0-1 points;
• Expected survival time ≥ 3 months;
• Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST \<1.5×ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy \<2000 IU/ml and ALT\<2×ULN; renal function: creatinine \<1.5×ULN and creatinine clearance rate ≥50ml/min;
• With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy;
• Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment;
• Voluntarily signing an informed consent form before trial screening.

You may not qualify if:

• Nodular lymphocyte predominant HL;
• Patients received any form of anti-tumor therapy in the past;
• Patients planning to receive radiotherapy or autologous stem cell transplantation;
• With involvement of central nervous system (meninges or brain parenchyma);
• Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures;
• Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation;
• Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment;
• Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment,
• Patients with known active interstitial pneumonia;
• Abnormal liver function (total bilirubin\>1.5×ULN, ALT/AST\>2.5×ULN or ALT/AST\>5×ULN for patients with liver invasion), abnormal renal function (serum creatinine\>1.5×ULN), abnormal electrolyte metabolism;
• Peripheral neuropathy ≥ Grade 2;
• Patients with a history of prolonged QT interval which is of clinical significance (male\> 450ms, female\> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug therapy;
• Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;
• Mentally disturbed/patients unable to give informed consent;
• Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

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

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: Professor

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 13, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)