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Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry (COMPLETE)

This study is currently recruiting participants.
Verified May 2013 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01110733
First received: April 23, 2010
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials.


Condition
Peripheral T-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Estimated Enrollment: 3000
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be enrolled from academic and community cancer centers in the United States, France, Germany, Italy and Japan.

Criteria

Inclusion Criteria:

  • Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):

    • Aggressive natural killer (NK)-cell leukemia
    • Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma (ALCL), primary systemic type (ALK+, ALK-)
    • PTCL, not otherwise specified (NOS)
    • T/NK-cell lymphoma, nasal type
    • Enteropathy-type intestinal lymphoma
    • Hepatosplenic T-cell lymphoma
    • Subcutaneous panniculitis T-cell lymphoma
    • Transformed mycosis fungoides (at diagnosis of transformation)
    • T-cell prolymphocytic leukemia (T-PLL)
    • Cutaneous gamma/delta (γ/δ) T-cell lymphoma
    • Cutaneous aggressive CD8+ T-cell lymphoma
    • Hematodermic neoplasms (blastic plasmacytoid dendritic cell neoplasm)
    • Systemic Epstein Barr Virus (EBV)+ T-cell lymphomas (T-cell lymphoproliferative disorders of childhood)
    • Other T-Cell lymphomas that are not listed in the Exclusion Criteria
  • Patient gives written informed consent

Exclusion Criteria:

  • Patient has other T- or NK-cell malignancies including:

    • Precursor T/NK neoplasms
    • T-cell large granular lymphocytic leukemia
    • Mycosis fungoides, other than transformed mycosis fungoides
    • Sézary syndrome
    • Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110733

Contacts
Contact: Heidi Vosseler 215-801-4017 complete.ptcl@actsolutions.org

  Show 75 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Chair: Francine Foss, MD Yale University
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01110733     History of Changes
Other Study ID Numbers: COMPLETE Registry
Study First Received: April 23, 2010
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Japan: Institutional Review Board

Keywords provided by Spectrum Pharmaceuticals, Inc:
Non-Hodgkins Lymphoma
Non-Hodgkin's Lymphoma
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 23, 2013