Phase IV study of Brentuximab Vedotin in Hodgkin Lymphoma

Phase 4

• Conditions: Health Condition 1: C810- Nodular lymphocyte predominant Hodgkin lymphoma

• Registration Number: CTRI/2024/07/069820
• Lead Sponsor: Baxalta US Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Treatment-naïve, HL patients with Ann Arbor Stage 3 or 4 disease (Section 17.4)

Note: Patients must have histologically confirmed classical HL according to the current World Health Organization Classification.

2.Patients must have bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma (Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ et al. International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86).

3.Male or female patients 18 years or older

4.Eastern cooperative oncology group (ECOG) performance status =2

5. Female patients who

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

5.2 Are surgically sterile, OR

5.3 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

5.4 Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the patient. (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).

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

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

6.2 Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the patient. (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).

7. 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 patient at any time without prejudice to future medical care.

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

8.1 Absolute neutrophil count = 1,000/µL unless there is known HL marrow involvement

8.2 Platelet count = 75,000/µL unless there is known HL marrow involvement

8.3 Total bilirubin must be less than 1.5 times upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.

8.4 Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be less than 3.0 times 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.

8.5 Serum creatinine must be less than 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance greater 30 mL/minute (Cockcroft-Gault Equation).

8.6 Hemoglobin must be greater than or equal to

Exclusion Criteria

1. Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug.

2. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.

3. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.

4. Any sensory or motor peripheral neuropathy.

5. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.

6. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.

7. Previously treated with brentuximab vedotin

8. Any contraindications to the concomitant chemotherapy regimens (doxorubicin, vinblastine, and dacarbazine).

9. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of AVD (doxorubicin, vinblastine, and dacarbazine).

10. Known human immunodeficiency virus (HIV) positive.

11. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

12. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

13. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:

13.1 A left-ventricular ejection fraction less than 50%

13.2 Myocardial infarction within 2 years of enrollment

13.3 New York Heart Association (NYHA) Class 3 or 4 heart failure. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

14. Any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.

Study & Design

• Study Type: PMS
• Study Design: Not specified