Conditions: Relapsed or Refractory Lymphoproliferative Malignancies Hodgkin's Lymphoma Peripheral T-cell Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia
Keywords: Lymphoproliferative malignancies Lymphoma Hodgkin's lymphoma (HL) Non-Hodgkin's lymphoma (NHL) PTCL T/NK-cell leukemia/lymphoma T-cell lymphoma/leukemia (HTLV 1+) Angioimmunoblastic T-cell lymphoma Blastic NK lymphoma Anaplastic large cell lymphoma T/NK-cell lymphoma Enteropathy-type intestinal lymphoma Hepatosplenic T-cell lymphoma Extranodal peripheral T/NK-cell lymphoma Subcutaneous panniculitis T-cell lymphoma Transformed mycosis fungoides PDX Pralatrexate Gemcitabine Gemzar Vitamin B12 Folic acid
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 119
Healthy volunteers: no

Brief summary:
This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia.

This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pralatrexate Injection intervention 2: Gemcitabine Hydrochloride intervention 3: Vitamin B12 intervention 4: Folic Acid
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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.

Protocol document: