Status:
UNKNOWN
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
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hodgkin Lymphoma
Chemotherapy Effect
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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. PD-1 antibody (tisle...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04843267
Start Date
May 1 2021
End Date
May 1 2025
Last Update
April 13 2021
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000