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
  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:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Estimated Enrollment: 3000
Study Start Date: February 2010
Estimated Study Completion Date: December 2017
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110733

  Show 68 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: February 5, 2014
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 August 20, 2014