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Clinical Trial 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 (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.


Clinical Trial 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 (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 (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 Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00001237
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date March 1989
Completion date April 2000

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