A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every >= 3 Week Brentuximab Vedotin
18 Years
N/A
Both
Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia
Trial Information
A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every >= 3 Week Brentuximab Vedotin
PRIMARY OBJECTIVES:
I. To estimate the response rate following weekly brentuximab vedotin (1.2mg/kg 3 of 4 weeks
for up to four 28-day cycles) in patients with lack of response (< partial response [PR]) or
progression following brentuximab vedotin and demonstrating persistent expression of CD30.
SECONDARY OBJECTIVES:
I. To monitor clinical outcome following the study treatment regimen. II. To estimate the
frequency of CD30 loss in patients following resistance to brentuximab vedotin.
III. To describe the pattern of CD30 expression (membranous, cytoplasmic, Golgi) in
comparison to the pre-brentuximab vedotin expression.
IV. To semi-quantitatively estimate and compare the surface density of CD30 pre and post
brentuximab vedotin as measured by flow cytometry.
V. To correlate response with CD30 density as measured by flow cytometry. VI. To evaluate
the tolerability of the weekly regimen in patients previously exposed to brentuximab
vedotin.
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and
15. Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months
for 1 year, and then every 6 months for 4 years.
Inclusion Criteria:
- Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab
vedotin (minimum of 2 cycles) or progressed while receiving brentuximab vedotin
- Documented expression of CD30 on tumor cells following the last dose of brentuximab
vedotin
- Absolute neutrophil count (ANC) > 1,000/uL
- Platelets > 50,000/uL
- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
- Bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- Measurable disease by computed tomography (CT) or similar (e.g. magnetic resonance
imaging [MRI]) criteria (> 1.5 cm)
- Resolution of all non-hematologic brentuximab vedotin-related adverse events (AEs) to
< Grade 2
- All patients must be informed of the investigational nature of this study and have
given written consent in accordance with institutional and federal guidelines
- Patients must be anticipated to complete at least 2 cycles of chemotherapy on study
- Expected survival if untreated of > 90 days
Exclusion Criteria:
- Prior transplant within 100 days
- Radioimmunotherapy within 12 weeks
- Known human immunodeficiency virus (HIV) or hepatitis B positivity
- Active infection or other medical condition which would preclude treatment in the
opinion of the principal investigator
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Known active central nervous system (CNS) involvement
- Peripheral neuropathy > Grade 1 if due to brentuximab vedotin or any peripheral
neuropathy > Grade 2
- Intolerance to brentuximab vedotin
- Concurrent use of other anti-cancer agents or experimental treatments
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 as measured by the Cheson 2007 criteria
Outcome Description:
No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is >= 20%.
Outcome Time Frame:
Up to 5 weeks after completion of study treatment
Safety Issue:
No
Principal Investigator
Ajay Gopal
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Food and Drug Administration
Study ID:
7808
NCT ID:
NCT01703949
Start Date:
March 2013
Completion Date:
Related Keywords:
- Adult Grade III Lymphomatoid Granulomatosis
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Noncutaneous Extranodal Lymphoma
- Peripheral T-cell Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Refractory Hairy Cell Leukemia
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Testicular Lymphoma
- Waldenström Macroglobulinemia
- Burkitt Lymphoma
- Hodgkin Disease
- Immunoblastic Lymphadenopathy
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Hairy Cell
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphomatoid Granulomatosis
- Lymphoproliferative Disorders
- Waldenstrom Macroglobulinemia
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Extranodal NK-T-Cell
- Lymphoma, Mantle-Cell
- Leukemia, Large Granular Lymphocytic
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
