Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Lymphoma
Interventions
BIOLOGICAL

filgrastim

Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

BIOLOGICAL

pegfilgrastim

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

BIOLOGICAL

rituximab

375 mg/m2 IV Day 1 of each cycle

BIOLOGICAL

sargramostim

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

DRUG

cyclophosphamide

750 mg/m2 IV Day 1 of each cycle

DRUG

pegylated liposomal doxorubicin hydrochloride

40 mg/m2 IV Day 1 of each cycle

DRUG

prednisone

100 mg PO Days 1-5 of each cycle

DRUG

vincristine sulfate

1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle

OTHER

immunohistochemistry staining method

tissue specimen collected at baseline

OTHER

laboratory biomarker analysis

tissue specimen collected at baseline

Trial Locations (14)

10065

Memorial Sloan-Kettering Cancer Center, New York

10461

Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx

19106

Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

70121

Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans

98101

Virginia Mason Medical Center, Seattle

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

90095-1793

UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

02118

Boston University Cancer Research Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

44106-5065

Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

AIDS Malignancy Consortium

NETWORK

NCT00389818 - Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter