Search / Trial NCT00001379

Treatment and Natural History Study of Lymphomatoid Granulomatosis

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

Trial Information

Current as of December 14, 2024

Active, not recruiting

Keywords

Epstein Barr Virus Lymphoproliferative Disorder Viral Immunosuppression Lymphoma

ClinConnect Summary

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 l...

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.

Trial Officials

Christopher J Melani, M.D.

Principal Investigator

National Cancer Institute (NCI)

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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