CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Pralatrexate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00998946
NCT00998946Phase 2Completed
CompareCT.gov

A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Spectrum Pharmaceuticals, Inc·interventional·Posted Oct 21, 2009·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating Pralatrexate, Vitamin B12, and 1 other intervention for Lymphoma, B-Cell. Completed, enrolled 29 participants across 11 sites.

Detailed Summary

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.7 years ago

Interventions

Pralatrexatedrug

Pralatrexate injection administered as intravenous (IV) push

Vitamin B12dietary

1 mg intramuscular (IM) injection

Folic Aciddietary

Oral 1 mg tablet