CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
granulocyte-macrophage colony stimulating factor (GM-CSF)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001237
NCT00001237Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Dec 10, 2002·Updated Mar 4, 2008

In Brief

A Phase 2 clinical trial evaluating granulocyte-macrophage colony stimulating factor (GM-CSF) for Burkitt Lymphoma and 2 related conditions. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2002
Enrollment StartMar 1, 1989
Study CompletionApr 1, 2000
TodayJul 2, 2026
Posted 23.6 years ago

Interventions

granulocyte-macrophage colony stimulating factor (GM-CSF)drug