The main aim of this study is to check how safe brentuximab vedotin is in adults with untreated Hodgkin Lymphoma (HL) when given together with doxorubicin (Adriamycin), vinblastine and dacarbazine therapy ('AVD'). Another aim is to learn how well treatment of brentuximab vedotin plus AVD works. All participants will receive brentuximab vedotin plus AVD for approximately 6 months. Participants will undergo tests like Echocardiography (ECHO) and pulmonary function testing (PFT) during the study. ECHO is a test that uses ultrasound to show how the heart muscle and valves are working; PFT is a test to check how well a participant's lungs work. Each participant will undergo a final health status check 2 months after the last treatment with brentuximab vedotin plus AVD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Brentuximab Vedotin IV infusion
Doxorubicin IV infusion
Vinblastine IV infusion
Dacarbazine IV infusion
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, India
RECRUITINGGauhati Medical college and Hospital
Guwahati, Assam, India
ACTIVE_NOT_RECRUITINGUnique Hospital Multispeciality and Research Institute
Surat, Gujarat, India
RECRUITINGHCG Cancer Centre
Bangalore, Karnataka, India
RECRUITINGJIPMER
Puducherry, Kerala, India
ACTIVE_NOT_RECRUITINGHCG Manavata Cancer Centre
Nashik, Maharashtra, India
ACTIVE_NOT_RECRUITINGACTREC
Navi Mumbai, Maharashtra, India
ACTIVE_NOT_RECRUITINGDMH
Pune, Maharashtra, India
ACTIVE_NOT_RECRUITINGRajiv Gandhi Cancer Hospital
Delhi, New Delhi, India
ACTIVE_NOT_RECRUITINGNRS Medical college & Hospital, Kolkata
Kolkata, West Bengal, India
RECRUITING...and 1 more locations
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a drug; it does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. ADRs are defined as AEs which are in the investigator's opinion of causal relationship to the study treatment. An unexpected ADR is an ADR with the nature, severity, or outcome which is not consistent with summary of product characteristics.
Time frame: Up to 40 weeks
Percentage of Participants Achieving Complete Remission (CR)
CR is defined as disappearance of all the evidence of disease assessed by investigator per Revised Response Criteria for Malignant Lymphoma.
Time frame: Up to 35 weeks
Objective Response Rate (ORR)
ORR is defined as the disappearance of all evidences of a disease along with a decrease in evidences of a disease (CR+ partial remission \[PR\]) assessed by investigator per Revised Response Criteria for Malignant Lymphoma.
Time frame: Up to 35 weeks
Positron Emission Tomography (PET) Negativity Rate at Cycle 2
The rate of PET negativity is the percentage of participants with PET negativity (defined as Deauville score 1, 2, or 3) at the end of Cycle 2. The Deauville 5-point scoring system is a five-point scoring system for the fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake \> mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In this study, scores of 1, 2, and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.
Time frame: Days 20 to 28 of Cycle 2 (cycle length=28 days)
Progression Free Survival (PFS)
PFS is defined as the time from study drug assignment to disease progression (PD) or death from any cause or date of last tumor assessment if the participant did not progress or die.
Time frame: Up to 40 weeks
Overall Survival (OS)
OS is defined as the time from study drug assignment to death from any cause or last date when the participant was known to be alive.
Time frame: Up to 40 weeks
Disease Free Survival
Disease free survival is measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment.
Time frame: Up to 40 weeks
Event Free Survival
Event free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason.
Time frame: Up to 40 weeks
Duration of Response (DOR)
DOR is defined as the time from first occurrence of overall response (CR or PR whichever is recorded first) after start of study treatment until the date of disease progression or relapse.
Time frame: Up to 40 weeks
Duration of Complete Remission (DOCR)
DOCR in participants with confirmed CR is the time between first documentation of CR and PD.
Time frame: Up to 40 weeks
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