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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies

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 Summary:
Sponsor: Spectrum Pharmaceuticals, Inc

Current Primary Outcome: Objective Responses Assessed by International Workshop Criteria (IWC) [ Time Frame: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I ]

Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.


Original Primary Outcome: Phase 1: MTD and recommended phase 2 dose, safety and tolerability, and PK profile. Phase 2a: tolerability and preliminary efficacy (based on investigator assessment of response) in relapsed/refractory PTCL.

Current Secondary Outcome:

  • Duration of Response [ Time Frame: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study ]
    Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
  • Progression-free Survival (PFS) Time [ Time Frame: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study ]
    PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).


Original Secondary Outcome:

Information By: Spectrum Pharmaceuticals, Inc

Dates:
Date Received: June 1, 2007
Date Started: May 2007
Date Completion:
Last Updated: May 8, 2013
Last Verified: May 2013