Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

May 31, 2011

Study Completion Date

August 31, 2011

Conditions
Relapsed or Refractory Lymphoproliferative MalignanciesHodgkin's LymphomaPeripheral T-cell LymphomaB-cell LymphomaWaldenstrom's Macroglobulinemia
Interventions
DRUG

Pralatrexate Injection

"Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).~Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.~Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."

DRUG

Gemcitabine Hydrochloride

"Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.~Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.~Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met."

DIETARY_SUPPLEMENT

Vitamin B12

"1 mg intramuscular injection~Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."

DIETARY_SUPPLEMENT

Folic Acid

"1 mg orally~Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate."

Trial Locations (15)

10016

New York University Hospital, New York

10017

Memorial Sloan-Kettering Cancer Center, New York

19111

Fox Chase Cancer Center, Philadelphia

29425

Medical University of South Carolina, Charleston

60637

University of Chicago Hospital, Chicago

63110

Washington University School of Medicine, St Louis

68198

University of Nebraska Medical Center, Omaha

77030

UT MD Anderson Cancer Center, Houston

80218

Rocky Mountain Cancer Center, Denver

94305

Stanford University School of Medicine, Stanford

98109

Fred Hutchinson Cancer Research Center, Seattle

90095-7077

University of California at Los Angeles, Los Angeles

02115-6013

Dana-Farber Cancer Institute, Boston

07601

The Cancer Center at Hackensack University Medical Center, Hackensack

78229-4427

Cancer Therapy & Research Center, San Antonio

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY