A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
This study is currently recruiting participants.
Verified March 2013 by Millennium Pharmaceuticals, Inc.
Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01578499
First received: March 27, 2012
Last updated: March 31, 2013
Last verified: March 2013
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Purpose
This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Cutaneous Anaplastic Large Cell Lymphoma, Mycosis Fungoides Cutaneous T-Cell Lymphoma |
Drug: Brentuximab Vedotin Drug: Methotrexate or Bexarotene |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Millennium Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Change in response at the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ Designated as safety issue: No ]To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
Secondary Outcome Measures:
- Proportion of patients achieving complete response (CR) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ Designated as safety issue: No ]To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm
- Progression-free survival (PFS) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ Designated as safety issue: No ]To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm
- Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Day 1 of 21 day cycles: 1,2,4,6,8,10,12,14, and 16; At EOT 30 days after the last dose, and during post treatment follow-up (for up to 3 years post treatment) ] [ Designated as safety issue: No ]To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm
| Estimated Enrollment: | 124 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methotrexate or Bexarotene
Methotrexate or Bexarotene as per physician's choice
|
Drug: Methotrexate or Bexarotene
Methotrexate will be administered orally (5 to 50 mg) once weekly. Dose adjustment is guided by patient response and toxicity or Bexarotene will be administered orally (300 mg/m2) once daily with meals.
|
|
Experimental: Brentuximab Vedotin
Brentuximab Vedotin Monotherapy
|
Drug: Brentuximab Vedotin
Brentuximab vedotin (1.8 mg/kg) will be administered intravenously over approximately 30 minutes once every 21 days and may continue as monotherapy for up to a total of 16 cycles (48 weeks)
Other Name: SGN-35
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Voluntary consent form
- Male or female patients 18 years or older with diagnosis of MF or pcALCL
- Patients must have received at least 1 prior systemic therapy for their disease
- Histologically confirmed CD30+ disease by central laboratory assessment and pathology review
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
- Clinical laboratory value as specified in protocol
Exclusion Criteria:
- A concurrent diagnosis of systemic ALCL,other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome
- Patients with cardiovascular conditions specified in protocols
- Patients with history of another primary malignancy not in remission for at least 3 years
- Known active cerebral/meningeal disease, HIV infection, hepatitis B or Hepatitis C infection
- Oral retinoid therapy for any indication within 12 weeks of study entry
- Corticosteroid therapy within 4 weeks or immunosuppressive chemotherapy or any immunotherapy within 12 weeks of first dose of study drug
- Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578499
Contacts
| Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-877-674-3784 | medical@mlnm.com |
Locations
| United States, California | |
| UCLA Hematology Oncology | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Herbert Eradat | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Lubomir Sokol, MD | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Boston University Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215-5450 | |
| Contact: David C Fisher | |
| United States, New Jersey | |
| John Theurer Cancer Center (Hackensack University Medical Center) | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Australia | |
| Concord Repatriation General Hospital | Recruiting |
| Concord, Australia | |
| Peter MacCallum Cancer Centre | Recruiting |
| East Melbourne, Australia | |
| Sir Charles Gairdner Hospital | Recruiting |
| Nedlands, Australia | |
| Belgium | |
| UZ Leuven | Recruiting |
| Leuven, Belgium | |
| Germany | |
| Klinik für Dermatologie, Venerologie und Allergologie | Recruiting |
| Kiel, Germany | |
| Italy | |
| A.O.U. Policlinico S.Orsola Malpighi | Recruiting |
| Bologna, Italy | |
| Spain | |
| Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| United Kingdom | |
| St. James University Hospital | Recruiting |
| Leeds, United Kingdom, LS9 7TF | |
| St. John's Institute of Dermatology | Recruiting |
| London, United Kingdom, SE1 EH | |
| Manchester Cancer Research Centre | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01578499 History of Changes |
| Other Study ID Numbers: | C25001, 2010-024215-14 |
| Study First Received: | March 27, 2012 |
| Last Updated: | March 31, 2013 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Mycoses Mycosis Fungoides Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, Large-Cell, Anaplastic Lymphoma, Primary Cutaneous Anaplastic Large Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate |
Bexarotene Antibodies, Monoclonal Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013