Search / Trial NCT00001237

Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Burkitt's Lymphoma Gm Csf High Grade

ClinConnect Summary

Major improvements in the treatment of childhood non-lymphoblastic lymphomas have taken place in the last ten years. Though the survival rate in low risk patients (i.e., those with stage I \& II disease and serum LDH of less than 350 IU/dL) was as high as 90% with the previous Pediatric Branch protocol, only 32% of patients in the high risk group achieved long term remission. The present protocol is designed to improve survival in the high risk group by using alternating non-cross resistant drug regimens. We plan to determine whether using granulocyte-macrophage colony stimulating factor (G...

Gender

ALL

Eligibility criteria

  • High Risk Protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas except those with:
  • • a) Minimal extra-abdominal tumor as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or except those with b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted) and a serum LDH level less than 1.5 times upper limit of normal (NIH patients less than 350 U/L).
  • • All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a serum LDH level greater than 1.5 times the upper limit of normal (NIH patients, greater than 350 U/L), regardless of the clinically documented extent of disease.
  • • All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with testicular involvement.
  • • Low risk protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a) minimal extra-abdominal disease as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted for gastrointestinal disease) and a serum LDH level less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L).
  • • No patients with lymphoblastic lymphomas, low grade or follicular lymphomas.
  • • No patients with peripheral T cell lymphomas that do not fall into the category of anaplastic large cell lymphoma.
  • • No patients with a previously documented lymphoma or histological evidence of co-existing lymphoma of other histology.
  • • No patients who have been previously treated with chemotherapy or radiotherapy.
  • • No patients with HIV infection.
  • • No patients above the age of 60 years.
  • • No patients with a history of inherited or non-HIV acquired immunodeficiency syndromes.

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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