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Study Summary
No. 2010-0776:.......Lymphoma......Michelle A. Fanale......Lymphoma
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Study Summary Title
Study Summary
Number:
2010-0776
Study Title:A Phase 1 Study of Brentuximab Vedotin Administered
Sequentially and Concurrently with Multi-Agent Chemotherapy
as Front-Line Treatment in Patients with CD30-Positive Mature
T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic
Large Cell Lymphoma
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Physician New Patient Referral
Name:Michelle A. FanalePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LymphomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2806
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:Seattle Genetics, Inc.
Phase of Study:Phase IReturn
Visit:
Treatment
Agents:
Cyclophosphamide
Doxorubicin
Prednisone
SGN-35
Vincristine
Home Care:
Treatment Loc:Both at MDACC & and Other Sites
Estimated
Length of Stay
in Houston:
Description/
Intervention:
The goal of this clinical research study is to learn about the safety and
effectiveness of brentuximab vedotin given before and after standard
chemotherapy called CHOP (cyclophosphamide, doxorubicin, vincristine, and
prednisone) and brentuximab vedotin given with and after a chemotherapy called
CH-P (cyclophosphamide, doxorubicin, and prednisone) in patients with ALCL.

Researchers also want to learn the highest tolerable dose of brentuximab
vedotin that can be given in combination with CH-P chemotherapy.
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Study Objectives / Outcomes
Primary Objectives
• To assess the safety profile of brentuximab vedotin in treatment-naïve systemic anaplastic large cell lymphoma (ALCL) patients when administered before, during, and after cyclophosphamide, doxorubicin, vincristine, and prednisone multi-agent chemotherapy
• To determine the maximum tolerated dose (MTD), if reached, of brentuximab vedotin
administered in combination with multi-agent chemotherapy
 To assess the safety profile of brentuximab vedotin in treatment-naïve patients with
CD30-positive mature T-cell and NK-cell neoplasms, including systemic ALCL,
when administered at the determined MTD during and after multi-agent
chemotherapy

Secondary Objectives
• To assess the antitumor activity of brentuximab vedotin in treatment-naïve systemic ALCL
patients when administered before multi-agent chemotherapy
• To assess the antitumor activity of brentuximab vedotin in treatment-naïve patients
with CD30-positive mature T-cell and NK-cell neoplasms, including systemic ALCL
when administered in combination with multi-agent chemotherapy
• To assess the pharmacokinetics of brentuximab vedotin in treatment-naïve patients
with CD30-positive mature T-cell and NK-cell neoplasms, including systemic ALCL
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:02/10/2011
Study Type:Phase I
Recruitment Status:Closed
Projected Accrual:52
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Treatment-naïve patients with CD30-positive mature T-cell and NK-cell neoplasms, including systemic ALCL patients with ALK negative disease or ALK positive disease; systemic ALCL patients with ALK positive disease must have an IPI score >/= 2

2) Histologically confirmed diagnosis of CD30-positive mature T-cell and NK-cell neoplasm, including systemic ALCL (tissue must be available for confirmation of pathology via slides or tumor block); ALK status for systemic ALCL patients must be documented

3) Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of at least 1.5 cm as documented by radiographic technique (spiral computed tomography [CT] preferred)

4) Eastern Cooperative Oncology Group (ECOG) performance status </= 2

5) Patients must be >/= 18 years of age

6) Patients must have the following baseline laboratory data: a. Absolute neutrophil count (ANC) >/= 1000/microL b. Platelet count >/= 75,000/microL (unless documented bone marrow involvement with lymphoma) c. Serum bilirubin level </= 1.5 x upper limit of normal (ULN) or </= 3 x ULN for patients with Gilbert's disease or documented hepatic involvement with lymphoma d. Serum creatinine </= 1.5 x ULN e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 3 x ULN

7) Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non childbearing potential are those who are post-menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy

8) 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 study drug

9) Patients or their legally authorized representative must provide written informed consent

Exclusion Criteria:1) History of another primary malignancy that has not been in remission for at least 3 years (The following are exempt from the three-year limit: 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 Papanicolau [PAP] smear.)

2) Current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible), mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type

3) Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML)

4) Left ventricular ejection fraction< 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months

5) Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin

6) Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status

7) Females who are pregnant or lactating

8) Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of CHOP

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Links
Registration Number: NCT01309789
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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