CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
pralatrexatedrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed Hodgkin's lymphoma or aggressive NHL (WHO classification): large B/T-cell, transformed lymphomas, mantle cell, or immunoblastic lymphoma
  • ✓At least 1 unidimensionally measurable lesion (≥2 cm by conventional CT or ≥1 cm by spiral CT; lymph nodes ≤1 cm considered normal)
  • ✓Relapsed or refractory disease after first-line chemotherapy
  • ✓Cohort 1: ≤3 prior cytotoxic chemotherapy regimens with PR lasting ≤6 months or refractory disease. Not eligible if refractory or relapsed <100 days from PBSC transplant.
Key exclusion· 7
  • ✕No clinically significant pleural effusions or ascites
  • ✕No active brain or leptomeningeal metastases (treated CNS disease allowed)
  • ✕No prior antifolate therapy
  • ✕No symptomatic congestive heart failure, NYHA class III–IV, unstable angina, cardiac arrhythmia, or MI/CVA/TIA within 6 months

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

Search/NCT00052442
NCT00052442Phase 2Completed
CompareCT.gov

A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphomas and Hodgkin's Disease

Spectrum Pharmaceuticals, Inc·interventional·Posted Jan 27, 2003·Updated Aug 25, 2021

In Brief

A Phase 2 clinical trial evaluating pralatrexate for Lymphoma. Completed, enrolled 72 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartAug 1, 2002
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 23.4 years ago

Interventions

pralatrexatedrug