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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01476410
Other study ID # NU 11H01
Secondary ID NCI-2011-00684ST
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date May 2021

Study information

Verified date February 2020
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.


Description:

LEAD IN: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

- Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible

- Stage II, III, and IV disease by Ann Arbor classification

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

- Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration

- Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration

- Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 45%

- Absolute neutrophil count (ANC) > 1000/mm^3

- Platelet count > 75,000/mm^3

- Creatinine < 2.5 mg/dl

- Bilirubin < 3.0 mg/dl

- Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters

- Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma

- Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug

- Patients must sign the informed consent form before registration

Exclusion Criteria:

- Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy

- History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])

- Known cerebral/meningeal disease

- Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose

- Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally [po] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended

- Patients with a known hypersensitivity to any excipient contained in the drug formulation

- Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
brentuximab vedotin
Given IV
doxorubicin hydrochloride
Given IV
vinblastine
Given IV
dacarbazine
Given IV
Procedure:
quality-of-life assessment
Ancillary studies
Genetic:
DNA analysis
Optional correlative studies
RNA analysis
Optional correlative studies
Radiation:
fludeoxyglucose F 18
Correlative studies
Procedure:
positron emission tomography
Correlative studies
Other:
laboratory biomarker analysis
Optional correlative studies
immunohistochemistry staining method
Optional correlative studies
Genetic:
polymorphism analysis
Optional correlative studies

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States NorthwesternU Chicago Illinois
United States University of Chicago Chicago Illinois
United States MD Anderson Cancer Center Houston Texas
United States Memorial Sloan- Kettering Cancer Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Stanford University Medical Center Stanford California

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University Robert H. Lurie Cancer Center, Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate after chemotherapy The primary objective of this study is to assess the overall response rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy 2 years
Secondary Overall response rate Overall response rate progression-free survival (PFS), time to treatment failure (TTF), freedom from progression (FFP), and overall survival (OS) rates following SGN-35/AVD sequential therapy. Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
Secondary Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]) Estimates of response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]) Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
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