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Study Summary
No. 2009-0801:.......Lymphoma......Michelle A. Fanale......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2009-0801
Study Title:A phase 1 dose-escalation safety study of brentuximab vedotin in
combination with multi-agent chemotherapy as frontline therapy
in patients with Hodgkin 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:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:Seattle Genetics, Inc.
Phase of Study:Phase IReturn
Visit:
Screening, cycle 1 day 1 and 15, Cycle 2 day 1, 15 and 28, Cycle 3-6 Day 1 and
Day 15, EOT
Treatment
Agents:
Adriamycin
Bleomycin
Dacarbazine
SGN-35
Vincristine
Home Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of brentuximab vedotin when given in combination with the chemotherapy
combination Adriamycin (doxorubicin), bleomycin, vinblastine, and dacarbazine
(known as ABVD) and when given combination with the chemotherapy combination
Adriamycin (doxorubicin), vinblastine, and dacarbazine (known as AVD) to
patients with Hodgkin lymphoma. The safety of this drug combination will also
be studied.
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Study Objectives / Outcomes
Primary Objectives
  • To assess the safety profile of brentuximab vedotin (SGN-35) in combination with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) and in combination with AVD (doxorubicin, vinblastine, dacarbazine) in treatment-naïve Hodgkin's Lymphoma (HL) patients with Stage IIa bulky disease or Stage IIb–IV disease
  • To determine the maximum tolerated dose (MTD), if reached, of brentuximab vedotin administered in combination with ABVD and in combination with AVD

Secondary Objectives
  • To assess the incidence of antitherapeutic antibodies (ATA)
  • To assess the pharmacokinetics of brentuximab vedotin when administered in combination with ABVD and when administered in combination with AVD
  • To assess the antitumor activity of brentuximab vedotin in combination with ABVD and in
combination with AVD
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Study Status Information
Study Activation / Registration Date:03/09/2010
IRB Review and Approval Date:03/09/2010
Study Type:Phase I
Recruitment Status:Closed
Projected Accrual:70
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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 HL patients with Stage IIa bulky disease or Stage IIb–IV disease.

2) Patients must have a histologically confirmed diagnosis of HL.

3) Patients must have bidimensional measurable disease of at least 1.5 cm as documented by radiographic technique (spiral computed tomography (CT) preferred).

4) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

5) Patients must be >= 18 years and <= 60 years of age.

6) Patients must have the following required baseline laboratory data: a. Absolute neutrophil count >=1,500/microL b. Platelet count>= 75,000/microL c. Serum bilirubin level <= 1.5 x upper limit of normal (ULN) d. Serum creatinine <=1.5 x ULN e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 x ULN.

7) Females of childbearing potential must have a negative serum or urine Beta-hCG pregnancy test result within 3 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

8) Both 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 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 3-year limit: nonmelanoma 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 PAP smear).

2) Known cerebral/meningeal disease.

3) Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 45%, coronary artery disease or arrhythmias.

4) Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators.

5) Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.

6) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first study dose.

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

8) Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy that is not completed 4 weeks prior to study entry.

9) Women who are pregnant or lactating.

10) Patients with a known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD.

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Links
Registration Number: NCT01060904
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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