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A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

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Trial Information

A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)


Inclusion Criteria:



- Patients with relapsed or refractory systemic ALCL who have previously received front
line chemotherapy.

- Documented anaplastic lymphoma kinase (ALK) status.

- Histologically-confirmed CD30-positive disease; tissue from the most recent post
diagnostic biopsy of relapsed/refractory disease must be available for confirmation
of CD30 expression via slides or tumor block.

- Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by
both positron emission tomography and spiral computed tomography.

- Received any previous autologous stem cell transplant at least 12 weeks (3 months)
prior.

- At US sites, patients greater than or equal to 12 years of age may be enrolled. At
non-US sites, patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

- Previous treatment with brentuximab vedotin.

- Previously received an allogeneic transplant.

- Patients with current diagnosis of primary cutaneous ALCL (patients who have
transformed to systemic ALCL are eligible).

- Known cerebral/meningeal disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate by Independent Review Group

Outcome Description:

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Dana Kennedy, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG035-0004

NCT ID:

NCT00866047

Start Date:

March 2009

Completion Date:

June 2016

Related Keywords:

  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Antigens, CD30
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • monomethyl auristatin E
  • Drug Therapy
  • Immunotherapy
  • Hematologic Diseases
  • Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Rocky Mountain Cancer CentersThornton, Colorado  80260
University of WashingtonSeattle, Washington  98195
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
Northwestern UniversityChicago, Illinois  60611
Mayo Clinic RochesterRochester, Minnesota  55905
Weill Cornell Medical CollegeNew York, New York  10021
Karmanos Cancer Institute / Wayne State UniversityDetroit, Michigan  48201
Baylor Sammons Cancer Center / Texas OncologyDallas, Texas  75246
MD Anderson Cancer Center / University of TexasHouston, Texas  77030-4003