Viewing Study NCT00001237



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001237
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Pilot Protocol for the Treatment of Patients With Small Non-Cleaved and Diffuse Large Cell Lymphomas
Status: COMPLETED
Status Verified Date: 2000-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 ie those with stage I II disease and serum LDH of less than 350 IUdL 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 GM-CSF in this group would increase dose-intensity and ameliorate myelotoxicity We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients
Detailed Description: 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 ie those with stage I II disease and serum LDH of less than 350 IUdL 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 GM-CSF in this group would increase dose-intensity and ameliorate myelotoxicity We also plan to study the effect on survival of decreasing the duration of treatment to three months from the present year-long therapy in low-risk patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
89-C-0041 None None None