Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab

PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

December 31, 2009

Study Completion Date

September 30, 2011

Conditions
Lymphoma
Interventions
DRUG

Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF

"Initial patients (n=9) received fludarabine (25 mg/m\^2 intravenously) and mitoxantrone (10 mg/m\^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m\^2) on day 8.~After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m\^2 intravenously) and cyclophosphamide (250 mg/m\^2 intravenously)with sequential administration of GM-CSF (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m\^2) on day 8. All patients received additional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management."

Trial Locations (1)

30322

Emory University Winship Cancer Institute, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Emory University

OTHER