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A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma


Phase 2
60 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma


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.


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not part of normal medical care, with the understanding that consent may be withdrawn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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate after chemotherapy

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Leo Gordon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 11H01

NCT ID:

NCT01476410

Start Date:

November 2011

Completion Date:

May 2018

Related Keywords:

  • 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
  • Hodgkin Disease
  • Lymphoma
  • Sclerosis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford University Medical CenterStanford, California  94305-5408
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
University of ChicagoChicago, Illinois  60637
NorthwesternUChicago, Illinois  60611
Memorial Sloan- Kettering Cancer CenterNew York, New York  10065