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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01110733
First received: April 23, 2010
Last updated: February 5, 2014
Last verified: February 2014

April 23, 2010
February 5, 2014
February 2010
February 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01110733 on ClinicalTrials.gov Archive Site
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Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry
Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Peripheral T-cell Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2017
February 2015   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01110733
COMPLETE Registry
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Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
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Study Chair: Francine Foss, MD Yale University
Spectrum Pharmaceuticals, Inc
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP