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

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    30
  • sponsor
    Sun Yat-sen University
Updated on 18 April 2021

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 (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for CR patients):

PD-1 antibody (tislelizumab), specification: 100mg/bottle. Usage and dosage: intravenous drip, 200mg each time, QD, D1. In the above PD-1 antibody single-drug regimen, 21 days are regarded as a treatment cycle, and all patients first receive 2 courses of PD-1 antibody single-drug induction treatment;

2. PET/CT mid-term efficacy evaluation used for guiding follow-up treatment options:

PET/CT efficacy evaluation before the 3rd course of treatment (PET/CT2):

CR patients: continue to receive PD-1 antibody monotherapy, and then receive 4 courses of PD-1 antibody therapy; PR patients: sequential 4 courses of PD-1 antibody + AVD combined chemotherapy; PD+SD patients: out group, and receive other anti-lymphoma therapy deemed suitable by the investigators;

After the 6th course, patients not out of the group receive PET/CT3 efficacy evaluation:

CR patients: end the treatment and enter the follow-up; PR patients: receive 2 more courses of PD-1 antibody + AVD combined chemotherapy, and then enter the follow-up.

3. PD-1 antibody + AVD combined treatment period (3rd-6th/8th course for PR patients):

PD-1 antibody, specification: 100mg/bottle. Usage and dosage: intravenous drip, 100mg each time, QD, d1, d15. AVD regimen Doxorubicin 25mg/m2, d1, d15 intravenous injection Vindesine 3mg/m2, d1, d15 intravenous injection Dacarbazine 0.375mg/m2, d1, d15 intravenous drip In this combined treatment regimen, every 28 days is a treatment cycle, and the PD-1 antibody is used in combination with AVD in D1 and D15 of each treatment cycle.

Details
Condition Hodgkin's Disease, Lymphoma, Chemotherapy Effect, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment tislelizumab
Clinical Study IdentifierNCT04843267
SponsorSun Yat-sen University
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: hodgkins lymphoma or Chemotherapy Effect or hodgkin's lymphomas or hodgkin or hodgkin lymphomas or Lymphoma or hodgkin's lymphoma or Hodgkin's Disease?
Do you have any of these conditions: hodgkin's lymphoma or hodgkin or Chemotherapy Effect or hodgkin's lymphomas or hodgkins lymphoma or hodgkin lymphomas or Lymphoma or Hodgkin's Disease?
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 1.5109/L, platelets 90109/L, hemoglobin 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST <1.5ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy <2000 IU/ml and ALT<2ULN; renal function: creatinine <1.5ULN 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 Criteria

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>1.5ULN, ALT/AST>2.5ULN or ALT/AST>5ULN for patients with liver invasion), abnormal renal function (serum creatinine>1.5ULN), 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
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