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

Last updated: April 12, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Platelet Disorders

Marginal Zone Lymphoma

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04843267
B2020-324-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed byhistopathology;
  2. Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)
  3. Patients not suitable for receiving radiotherapy subsequently
  4. Patients with at least one assessable lesion (according to Lugano 2014 standard);
  5. Age 18 or above (including 18), no gender requirement;
  6. ECOG PS score of 0-1 points;
  7. Expected survival time ≥ 3 months;
  8. Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L,hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, totalbilirubin, ALT and AST <1.5×ULN (upper limit of normal); patients with hepatitis Bneed 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;
  9. With normal main indicators of cardio-pulmonary function, and no obviouscontraindication to chemotherapy;
  10. Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targetedtherapy, cellular immunotherapy or hematopoietic stem cell transplantation beforeenrollment;
  11. Voluntarily signing an informed consent form before trial screening.

Exclusion

Exclusion Criteria:

  1. Nodular lymphocyte predominant HL;
  2. Patients received any form of anti-tumor therapy in the past;
  3. Patients planning to receive radiotherapy or autologous stem cell transplantation;
  4. With involvement of central nervous system (meninges or brain parenchyma);
  5. Pregnant and lactating women and child-bearing patients who are unwilling to takecontraceptive measures;
  6. Patients with history of other tumors, except for cured cervical cancer orskin basalcell carcinoma; patients who have received organ transplantation;
  7. Patients who have received symptomatic treatment of myelosuppressive toxicity within 7days before enrollment;
  8. Patients who have used any immunosuppressive drugs within 4 weeks before thefirst-dose treatment,
  9. Patients with known active interstitial pneumonia;
  10. Abnormal liver function (total bilirubin>1.5×ULN, ALT/AST>2.5×ULN or ALT/AST>5×ULN forpatients with liver invasion), abnormal renal function (serum creatinine>1.5×ULN),abnormal electrolyte metabolism;
  11. Peripheral neuropathy ≥ Grade 2;
  12. 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;
  13. Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;
  14. Mentally disturbed/patients unable to give informed consent;
  15. Patients who affect the evaluation of test results due to drug abuse or long-termalcohol abuse;
  16. Participating in another interventional clinical study at the same time; Patients notsuitable to participate in this trial by the judgment of investigators.

Study Design

Total Participants: 30
Study Start date:
May 01, 2021
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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