A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine in Indian Patients With Untreated Stage 3/4 Classical Hodgkin Lymphoma

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Treatment-naïve, Hodgkin lymphoma (HL) participants with Ann Arbor Stage 3 or 4 disease.

⁃ Note: Participants must have histologically confirmed classical HL according to the current world health organization classification.

⁃ Participants must have bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred) per the international working group revised criteria for response assessment for malignant lymphoma.

⁃ Male or female participants 18 years or older.

⁃ Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.

⁃ Female participants who:

∙ Are postmenopausal for at least 1 year before the screening visit, OR

‣ Are surgically sterile, OR

‣ If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the informed consent form (ICF) through 6 months after the last dose of study drug, OR

‣ Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).

⁃ Male participants, even if surgically sterilized (i.e., status post-vasectomy), who:

∙ Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR

‣ Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).

⁃ Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

⁃ Clinical laboratory values as specified below within 7 days before the first dose of study drug:

∙ Absolute neutrophil count greater than or equal to (≥)1,000 per microliter (1,000/μL) unless there is known HL marrow involvement

‣ Platelet count ≥75,000/μL unless there is known HL marrow involvement

‣ Total bilirubin must be lesser than (\<)1.5 x upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.

‣ Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be \<3.0 x ULN. An AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.

• Note: Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria.

• Serum creatinine must be \<2.0 milligrams per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance \>30 mL/minute (Cockcroft-Gault Equation).

• Hemoglobin must be ≥8 grams per deciliter (g/dL).

Locations
Other Locations
India
HCG Cancer Centre
NOT_YET_RECRUITING
Bangalore
Rajiv Gandhi Cancer Hospital
RECRUITING
Delhi
Gauhati Medical college and Hospital
RECRUITING
Guwahati
NRS Medical college & Hospital, Kolkata
RECRUITING
Kolkata
HCG Manavata Cancer Centre
NOT_YET_RECRUITING
Nashik
ACTREC
NOT_YET_RECRUITING
Navi Mumbai
AIIMS
RECRUITING
New Delhi
JIPMER
RECRUITING
Puducherry
DMH
RECRUITING
Pune
Unique Hospital Multispeciality and Research Institute
RECRUITING
Surat
HCG City Cancer Centre
RECRUITING
Vijayawada
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 124
Treatments
Experimental: Brentuximab Vedotin 1.2 mg/kg
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.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov