Health Condition 1: C817- Other Hodgkin lymphoma
Conditions
Interventions
Intervention1: Risk Stratified approach: In this approach the treatment is based on the risk factor score (if low risk factor then ABVD protocol whereas if high risk factor then BEACOPP protocol) at t
Sponsors
Tata Research Administrative Council TRAC
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from progression (FFP) will be measured and compared between ABVD arm and risk-stratified/ response-adapted approach and is defined from the date of diagnosis to the date of first progression or relapse, need for alternate therapy (Escalation of therapy), or death as a result of treatment toxicity; deaths from unrelated causes will be censored.Timepoint: 3 years of follow up of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicities will be recorded and compared between the two arms as per CTCAE v5Timepoint: Monthly at every cycle of treatment and during follow up;Late toxicities will be recorded and compared between the two arms as per CTCAE v5.Timepoint: 10 years of follow up of treatment;Overall survival (OS): will be calculated from the date of diagnosis to the date of death as a result of any cause or date last known alive.Timepoint: 10 years of follow up of treatment;Progression-free survival: This will be measured and compared between the two arms of the study and is defined from the date of randomization to date of the first appearance of disease progression, relapse or death from any cause. Patients alive without progression or relapse will be censored at the date last known to be aliveTimepoint: 10 years of follow up of treatment;Quality of life assessment will be compared between the two strategies while on treatment and on follow-up till 2 years.Timepoint: Before starting the treatment. At the end of 2 cycles of chemotherapy. After the end of treatment. On the first follow up visit. Follow up visit after 1 year. Follow up visit after 2 year. In case of relapse. | — |
Countries
India
Contacts
Public ContactDr Hasmukh Jain
Tata Memorial Centre
Outcome results
None listed