A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
- Conditions
- Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT06831370
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brentuximab Vedotin 1.2 mg/kg Brentuximab Vedotin Participants will receive 1.2 milligrams per kilogram (mg/kg) brentuximab vedotin intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle, within 1 hour after completion of treatment with other agents \[25 milligrams per meter square (mg/m\^2) doxorubicin, 6 mg/m\^2 vinblastine and 375 mg/m\^2 dacarbazine IV infusions\] for a maximum of 6 cycles. Brentuximab Vedotin 1.2 mg/kg Doxorubicin Participants will receive 1.2 milligrams per kilogram (mg/kg) brentuximab vedotin intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle, within 1 hour after completion of treatment with other agents \[25 milligrams per meter square (mg/m\^2) doxorubicin, 6 mg/m\^2 vinblastine and 375 mg/m\^2 dacarbazine IV infusions\] for a maximum of 6 cycles. Brentuximab Vedotin 1.2 mg/kg Vinblastine Participants will receive 1.2 milligrams per kilogram (mg/kg) brentuximab vedotin intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle, within 1 hour after completion of treatment with other agents \[25 milligrams per meter square (mg/m\^2) doxorubicin, 6 mg/m\^2 vinblastine and 375 mg/m\^2 dacarbazine IV infusions\] for a maximum of 6 cycles. Brentuximab Vedotin 1.2 mg/kg Dacarbazine Participants will receive 1.2 milligrams per kilogram (mg/kg) brentuximab vedotin intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle, within 1 hour after completion of treatment with other agents \[25 milligrams per meter square (mg/m\^2) doxorubicin, 6 mg/m\^2 vinblastine and 375 mg/m\^2 dacarbazine IV infusions\] for a maximum of 6 cycles.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs Up to 40 weeks 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to 40 weeks 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.
Percentage of Participants Achieving Complete Remission (CR) Up to 35 weeks CR is defined as disappearance of all the evidence of disease assessed by investigator per Revised Response Criteria for Malignant Lymphoma.
Objective Response Rate (ORR) Up to 35 weeks 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.
Positron Emission Tomography (PET) Negativity Rate at Cycle 2 Days 20 to 28 of Cycle 2 (cycle length=28 days) 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.
Progression Free Survival (PFS) Up to 40 weeks 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.
Overall Survival (OS) Up to 40 weeks 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.
Disease Free Survival Up to 40 weeks 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.
Event Free Survival Up to 40 weeks 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.
Duration of Complete Remission (DOCR) Up to 40 weeks DOCR in participants with confirmed CR is the time between first documentation of CR and PD.
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Trial Locations
- Locations (11)
HCG City Cancer Centre
🇮🇳Vijayawada, Andhra Pradesh, India
Gauhati Medical college and Hospital
🇮🇳Guwahati, Assam, India
Unique Hospital Multispeciality and Research Institute
🇮🇳Surat, Gujarat, India
HCG Cancer Centre
🇮🇳Bangalore, Karnataka, India
JIPMER
🇮🇳Puducherry, Kerala, India
HCG Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
ACTREC
🇮🇳Navi Mumbai, Maharashtra, India
DMH
🇮🇳Pune, Maharashtra, India
Rajiv Gandhi Cancer Hospital
🇮🇳Delhi, New Delhi, India
NRS Medical college & Hospital, Kolkata
🇮🇳Kolkata, West Bengal, India
AIIMS
🇮🇳New Delhi, India