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LCCC 1115: A Pilot Feasibility Trial of Induction Chemotherapy With ABVD Followed by Brentuximab Vedotin (SGN-35) Consolidation in Patients With Previously Untreated Non-Bulky Stage I or II Hodgkin Lymphoma (HL)


N/A
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin Lymphoma, Adult

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Trial Information

LCCC 1115: A Pilot Feasibility Trial of Induction Chemotherapy With ABVD Followed by Brentuximab Vedotin (SGN-35) Consolidation in Patients With Previously Untreated Non-Bulky Stage I or II Hodgkin Lymphoma (HL)


This study is designed as a single arm pilot feasibility trial using an induction of 2-6
cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed
by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients
with stage I and II non-bulky Hodgkin Lymphoma (HL).

Feasibility will be determined by the percentage of patients who have no clinical evidence
of HL, and achieve PET negative disease post brentuximab consolidation. We anticipate
approximately 20 patients will be eligible across participating centers (including UNC, Mayo
Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year period. A future phase II study
evaluating progression free survival (PFS) after ABVD followed by brentuximab vedotin will
be considered feasible if ≥ 13 of 15 patients enrolled in this pilot trial become PET
negative after brentuximab vedotin consolidation.


Inclusion Criteria:



- Previously untreated stage I or II non-bulky Hodgkin lymphoma

- No mediastinal mass >0.33 maximum intrathoracic diameter on chest x-ray (see
Appendix B)

- No adenopathy ≥7.5 cm in its largest diameter

- Measurable disease as assessed by 2 dimensional measurement by CT (>2cm or 1.5 cm if
0.5 cm slices are used, as in spiral CT scan)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Age ≥18 years and ≤60 years of age

- Life expectancy of at least 3 months

- Adequate bone marrow function (without transfusion support within one week of
screening) as demonstrated by:

- Hemoglobin ≥ 8 g/dL

- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

- Platelet count ≥ 75,000/mm3

- Adequate hepatic and renal function as demonstrated by:

- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)

- Total serum bilirubin ≤1.5 x ULN

- Serum creatinine ≤ 2.0 mg/dL

- Negative serum β-hCG pregnancy test within 72 hours of day 1 of treatment with ABVD
in women of child-bearing potential

- Females of childbearing potential, and males who have partners of childbearing
potential must agree to use an effective contraceptive method during the study and
for 6 months following the last dose of brentuximab vedotin. Effective contraception
is defined as any medically recommended method (or combination of methods) as per
standard of care, including abstinence. Females of non-childbearing potential are
those who are postmenopausal greater than 1 year or who have had a bilateral tubal
ligation or hysterectomy.

- Signed an institutional review board (IRB)-approved informed consent document for
this protocol

Prior to Day 1 of brentuximab vedotin, patients must again meet the following inclusion
criteria:

- Adequate bone marrow function (without transfusion support within one week of D1 of
brentuximab vedotin) as demonstrated by:

- Hemoglobin ≥ 8 g/dL

- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

- Platelet count ≥ 75,000/mm3

- Adequate hepatic and renal function as demonstrated by:

- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)

- Total serum bilirubin ≤1.5 x ULN

- Serum creatinine ≤ 2.0 mg/dL

- Achieved at least a PR (and not progressed) after ABVD therapy

Exclusion Criteria:

- Prior therapies for treatment of HL including involved field radiation therapy or any
prior treatment for any malignancy with anthracyclines.

- Bulky disease (defined as a mass measuring > 7.5 cm or one-third the maximal diameter
of the thoracic cavity)

- Known CNS involvement

- Symptomatic pulmonary disease currently requiring regular medication including but
not restricted to bronchodilators

- Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C
(testing is not necessary if patient does not have history of these diseases, and no
risk factors for acquisition of these viruses)

- Cardiac disease with left ventricular ejection fraction of less than 45%

- Known hypersensitivity to any excipient contained in the drug formulation of
brentuximab vedotin or any component of ABVD

- Medical or other condition that would represent an inappropriate risk to the patient
or would likely compromise achievement of the primary study objective

- Other active malignancies with the exception of:

- Non-melanoma skin cancer

- Cervical carcinoma in situ without evidence of disease

- Prostatic intraepithelial neoplasia without evidence of prostate cancer

- Pregnant or lactating women

Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the
criteria below:

- Symptomatic pulmonary disease currently requiring regular medication including but
not restricted to bronchodilators

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility

Outcome Description:

Percentage of patients who convert to PET negative disease post consolidation.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Steven Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

LCCC 1115

NCT ID:

NCT01578967

Start Date:

April 2012

Completion Date:

January 2016

Related Keywords:

  • Hodgkin Lymphoma, Adult
  • Hodgkin's lymphoma
  • Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Mayo ClinicRochester, Minnesota  55905
Vanderbilt UniversityNashville, Tennessee  37232-6305
Rex Cancer CenterRaleigh, North Carolina  27607
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599