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/AClinical Study ID
NCT04843267
B2020-324-01
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed byhistopathology;
- 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, 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;
- With normal main indicators of cardio-pulmonary function, and no obviouscontraindication to chemotherapy;
- Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targetedtherapy, cellular immunotherapy or hematopoietic stem cell transplantation beforeenrollment;
- Voluntarily signing an informed consent form before trial screening.
Exclusion
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 takecontraceptive measures;
- Patients with history of other tumors, except for cured cervical cancer orskin basalcell carcinoma; patients who have received organ transplantation;
- Patients who have received symptomatic treatment of myelosuppressive toxicity within 7days before enrollment;
- Patients who have used any immunosuppressive drugs within 4 weeks before thefirst-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 forpatients 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-termalcohol abuse;
- 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
ChinaActive - Recruiting
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