Trial record 1 of 1 for:    A phase II trial of sequential SGN35 therapy with Adriamycin, vinblastine, and dacarbazine (S-AVD) for older patients with untreated Hodgkin lymphoma
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Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborators:
Robert H. Lurie Cancer Center
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01476410
First received: October 18, 2011
Last updated: September 8, 2014
Last verified: September 2014

October 18, 2011
September 8, 2014
November 2011
May 2016   (final data collection date for primary outcome measure)
Overall response rate after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01476410 on ClinicalTrials.gov Archive Site
  • Overall response rate [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.
  • Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Estimates of response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD])
Same as current
Not Provided
Not Provided
 
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Lymphocyte Depletion Hodgkin Lymphoma
  • Adult Lymphocyte Predominant Hodgkin Lymphoma
  • Adult Mixed Cellularity Hodgkin Lymphoma
  • Adult Nodular Sclerosis Hodgkin Lymphoma
  • Stage II Adult Hodgkin Lymphoma
  • Stage III Adult Hodgkin Lymphoma
  • Stage IV Adult Hodgkin Lymphoma
  • Drug: brentuximab vedotin
    Given IV
    Other Names:
    • anti-CD30 ADC SGN-35
    • anti-CD30 antibody-drug conjugate SGN-35
    • antibody-drug conjugate SGN-35
    • SGN-35
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • ADM
    • ADR
    • Adria
    • Adriamycin PFS
    • Adriamycin RDF
  • Drug: vinblastine
    Given IV
    Other Names:
    • Velban
    • Velsar
    • VLB
  • Drug: dacarbazine
    Given IV
    Other Names:
    • DIC
    • DTIC
    • DTIC-Dome
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Genetic: DNA analysis
    Optional correlative studies
  • Genetic: RNA analysis
    Optional correlative studies
  • Radiation: fludeoxyglucose F 18
    Correlative studies
    Other Names:
    • 18FDG
    • FDG
  • Procedure: positron emission tomography
    Correlative studies
    Other Names:
    • FDG-PET
    • PET
    • PET scan
    • tomography, emission computed
  • Other: laboratory biomarker analysis
    Optional correlative studies
  • Other: immunohistochemistry staining method
    Optional correlative studies
    Other Name: immunohistochemistry
  • Genetic: polymorphism analysis
    Optional correlative studies
Experimental: Treatment (antibody-drug conjugate and combination chemo)

LEAD-IN: Patients receive brentuximab vedotin 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.

Interventions:
  • Drug: brentuximab vedotin
  • Drug: doxorubicin hydrochloride
  • Drug: vinblastine
  • Drug: dacarbazine
  • Procedure: quality-of-life assessment
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Radiation: fludeoxyglucose F 18
  • Procedure: positron emission tomography
  • Other: laboratory biomarker analysis
  • Other: immunohistochemistry staining method
  • Genetic: polymorphism analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
May 2018
May 2016   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Study Coordinator (312)695-1301 cancertrials@northwestern.edu
United States
 
NCT01476410
NU 11H01, NCI-2011-00684, STU00046908
Yes
Northwestern University
Northwestern University
  • Robert H. Lurie Cancer Center
  • Seattle Genetics, Inc.
Principal Investigator: Leo Gordon Northwestern University
Northwestern University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP