Search / Trial NCT00001379

Treatment and Natural History Study of Lymphomatoid Granulomatosis

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Active, not recruiting

Keywords

Epstein Barr Virus Lymphoproliferative Disorder Viral Immunosuppression Lymphoma

Description

BACKGROUND: Lymphomatoid granulomatosis (LYG) is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs, skin, kidneys, and central nervous system. It is divided into three grades, depending on the degree of necrosis and cellular atypia. The grades of disease are histologically-based and do not necessarily correlate with clinical outcome. However, like other EBV related LPD's, LYG can transform into an aggressive large B-cell lymphoma, which would be included within the grade 3 category. It is important to note that not all grade 3 lesions are a large...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Patients must have a tissue-diagnosis of grade 1, 2 and/or 3 LYG (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, NCI. Final histopathologic classification and pathologic grade will be determined by Stephania Pittaluga, M.D. or her designee.
  • Patients with any stage of disease will be eligible.
  • Previously untreated and treated patients are eligible.
  • Patients age 12 or older will be eligible.
  • EXCLUSION CRITERIA:
  • Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive. DA-Epoch-R chemotherapy.
  • Patients with significant renal (Cr. greater than 1.5 mg/dl or creatinine less than 40 cc/min) or hepatic (bilirubin greater than 2.5 u) dysfunction not due to tumor involvement will not be eligible to receive DA-EPOCH-R chemotherapy.
  • Informed consent must be obtained.
  • Patients who in the opinion of the principle investigator are poor psychiatric or medical risk are not eligible.
  • Patients who received > 450 mg/m2 doxorubicin and have a cardiac ejection fraction on echocardiogram less than or equal to 40% on protocol entry are not eligible to received DA-EPOCH-R.
  • Patients with prior hepatitis B exposure may be included in the study provided that they have HBV DNA levels below the World Health Organization s cutoff of 100 IU/mL prior to starting therapy.

Attachments

readout_NCT00001379_2024-06-14.pdf

4.5 MB

NCT00001379_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

After completion of treatment

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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