Prospective, Longitudinal, Multinational Registry of Patients with Newly Diagnosed Peripheral T-Cell Lymphoma

Study ID
STU 022011-185

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital—St. Paul

Contact
Joyce Bolluyt
214-648-7007
joyce.bolluyt@utsouthwestern.edu

Principal Investigator
Madhuri Vusirikala

Summary

This is a prospective, longitudinal, multinational observational study. While patients may receive experimental interventions in the course of their care, the Registry is not designed to test any specific intervention. Patients enrolled in the Registry will undergo routine clinical assessments and receive therapy prescribed by their treating physicians.

It is expected that approximately 75 sites will participate in the Registry although no limit on site participation has been set. Both academic and community practices are expected to contribute patients to the Registry.

The precise number of patients who will participate in the Registry is not known at the present time. There are an estimated ~6,000 new cases of T-cell lymphoma diagnosed each year in the United States and a comparable number in the five large countries of Western Europe. Excluding the more indolent forms of the disease, the number of eligible patients for the PTCL Registry is expected to be approximately half of the estimated total. Participating investigators are strongly encouraged to approach all eligible patients to discuss Registry participation. An estimated 4 patients will be enrolled in this registry at UTSW and/or Parkland.

The Registry is anticipated to run for >=3 years.

Participant Eligibility

Newly diagnosed, histologically/cytologically confirmed 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

* 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 [LowerCase GAMA]/[LowerCase DELTA] 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 not excluded