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Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

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ClinicalTrials.gov Identifier: NCT01396070
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Youn Kim, Stanford University

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 18, 2011
Results First Submitted Date  ICMJE December 28, 2016
Results First Posted Date  ICMJE April 5, 2017
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
Overall Response Rate (ORR) [ Time Frame: 2 years ]
Overall response rate of brentuximab vedotin in this study population.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Objective clinical response rate assessed by the standard response criteria used in MF (Mycosis fungoides) and SS (Sezary syndromel) [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT01396070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • Overall Stable Disease Rate [ Time Frame: 2 years ]
    Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
  • Overall Partial Response Rate [ Time Frame: 2 years ]
    Overall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable.
  • Overall Non-Evaluable Response [ Time Frame: 4 weeks ]
    Overall Non-Evaluable Response of full patient population 3 subjects were not evaluable.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Official Title  ICMJE Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
Brief Summary The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.
Detailed Description

This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.

The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkin Lymphoma (NHL)
  • Cutaneous Lymphoma
  • Cutaneous T-cell Lymphoma (CTCL)
  • Mycosis Fungoides
  • Sezary Syndrome
Intervention  ICMJE Drug: Brentuximab vedotin

1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).

Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.

Other Names:
  • Adcetris
  • SGN-35
Study Arms  ICMJE Experimental: Brentuximab vedotin
Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
Intervention: Drug: Brentuximab vedotin
Publications * Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. doi: 10.1200/JCO.2014.60.3969. Epub 2015 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2014)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2011)
18
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication
  • At least the following wash-out from prior treatments:

    • ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody)
    • > 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy
    • > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
  • At least 18 years of age
  • ECOG performance status of ≤ 2
  • Must be able to commit to study schedule
  • Absolute neutrophil count (ANC) ≥ 1000/uL
  • Platelets ≥ 50,000/uL
  • Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN)
  • Serum creatinine ≤ 2X ULN
  • Alanine aminotransferase (ALT) ≤ 3X ULN
  • Aspartate aminotransferase (AST) ≤ 3X ULN
  • Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease
  • Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day)
  • Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
  • Known to be Hepatitis B or Hepatitis C antibody positive
  • HIV-positive with have a measurable viral load while on antiretroviral medication
  • Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy).
  • Pregnant
  • Breastfeeding
  • Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
  • Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment.
  • Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01396070
Other Study ID Numbers  ICMJE IRB-21324
LYMNHL0089 ( Other Identifier: OnCore )
SU-06212011-7946 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Youn Kim, Stanford University
Study Sponsor  ICMJE Youn Kim
Collaborators  ICMJE Seattle Genetics, Inc.
Investigators  ICMJE
Principal Investigator: Youn H Kim Stanford University
PRS Account Stanford University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP