drugset / Trial / NCT00455897

CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

NCT00455897 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.

Timeline

Start
2006-12
Primary completion
2007-11
Completion
2011-07

Outcome

Outcome not reported

Stopped (Enrollment): “Accrual was too slow. Trial terminated”

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-CSF Protein / enzyme biologic — —
Background Cyclophosphamide Other / unclassified — —
Background Doxorubicin Other / unclassified — —
Background Prednisone Other / unclassified — —
Background Rituximab Monoclonal antibody — —
Background Vincristine Small molecule — —