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A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.


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

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Trial Information

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.


Inclusion Criteria:



- Patients must have histologically confirmed CD30-positive hematologic malignancy.

- Patients with HL must have failed systemic chemotherapy either as induction
therapy for advanced stage disease or salvage therapy after initial
radiotherapy for early stage disease and were ineligible for, refused treatment
by, or previously received stem cell transplant.

- Patients must have measurable disease of at least 10mm as documented by radiographic
technique.

- Must be at least 18 years of age.

Exclusion Criteria:

- Patients with current diagnosis of pcALCL (systemic ALCL eligible).

- Patients with 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

Andres Forero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

SG035-0001

NCT ID:

NCT00430846

Start Date:

November 2006

Completion Date:

July 2009

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Antigens,CD30
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • 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
  • Hematologic Neoplasms

Name

Location
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Washington University St. Louis, Missouri  63110
Weill Cornell Medical College New York, New York  10021
University of Texas/MD Anderson Cancer Center Houston, Texas  77030