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A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies


Phase 1
12 Years
N/A
Not Enrolling
Both
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

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Trial Information

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies


Inclusion Criteria:



- Histologically confirmed CD30-positive hematologic malignancy.

- Patients with HL must have failed systemic chemotherapy.

- Patients with other CD30-positive malignancies (including ALCL) must be beyond first
remission or refractory to front line chemotherapy.

- Patients must have measurable disease of at least 1.5 cm as documented by
radiographic technique.

Exclusion Criteria:

- Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).

- History of allogeneic stem cell transplant.

- Patients who have had previous treatment with any anti-CD30 antibody.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and laboratory abnormalities

Outcome Time Frame:

1 month after last dose

Safety Issue:

Yes

Principal Investigator

Dana Kennedy, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG035-0002

NCT ID:

NCT00649584

Start Date:

March 2008

Completion Date:

February 2010

Related Keywords:

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

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
University of MiamiMiami, Florida  33136