A phase III randomized study to compare a risk-stratified and response-adapted strategy to ABVD regimen in adolescents and adults with advanced-stage Hodgkin lymphoma.

Tata Research Administrative Council TRAC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1)ECOG Performance status- 0-3 after prephase (If administered).
•2)Advanced stage Hodgkin’s lymphoma- Lugano stage III and IV disease will be considered, also stage IIA/B with any one of the adverse features like bulky mediastinum, bulky node more than 10cm in diameter, extranodal disease will be included.
•3)Adequate hematopoietic reserve- Platelet count >100,000/mm3, Neutrophil count >1500/mm3. Patients with cytopenias due to the bone marrow involvement or HLH will be considered for enrollment.
•4)Adequate organ function- Creatinine clearance >60 ml/min/1.73m2 BSA (Cockcroft-Gault equation), AST and ALT <2.5times the upper limit of normal, unless elevated due to disease involvement and total bilirubin <3mg/dL or less than twice the upper limit of normal (unless elevated due to Gilbert syndrome).
•5)Adequate cardiac function with a Left ventricular ejection fraction >50%.
•6)Adequate pulmonary reserve with normal or mild impairment in pulmonary function tests. Diffusion capacity within 25% of the normal predicted value for the patient unless the patient has lung involvement by lymphoma.
•7)Life expectancy >3months
•8)Women of childbearing age to use appropriate contraception.
•9)Willing to comply for follow-up.
•10)Access for a PET-CT scan

•1)Presence of an active uncontrolled infection.
•2)Cardiac comorbidities such as decompensation cardiac failure, coronary artery disease, uncontrolled arrhythmias, uncontrolled hypertension.
•3)Uncontrolled diabetes mellitus
•4)History of malignancy except for skin malignancy (completely excised basal or squamous cell carcinoma) or in-situ cervical carcinoma in the last 10 years. For other malignancies, if the time since the diagnosis is more than 3 years and the patient is in continuous remission they can be considered for the study.
•5)History of receiving treatment in the past for Hodgkin’s lymphoma, the exception being the use of corticosteroids for up to a week.
•6)History of receiving anthracyclines in the past for any other malignancy.
•7)Known positive serology (HIV)
•8)Involvement of the central nervous system by the lymphoma.
•9)Medical or psychiatric illness that may cause non-compliance or giving informed consent.
•10)Hodgkin’s lymphoma as a part of composite lymphoma.
•11)General intolerance of any protocol medication.

发起方

Tata Research Administrative Council TRAC