CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
CLOFARABINEdrug
Likely dose
Clofarabine 4 mg/m² intravenously days 1-5 of each cycle for up to 6 cyclesAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed diffuse large cell B-cell NHL with documented failure of prior systemic chemotherapy (with or without monoclonal antibodies)
  • ✓Measurable disease by CT/PET (≥1.0 cm longest diameter) or palpable lesions (both diameters ≥2.0 cm)
  • ✓ECOG performance status 0, 1, or 2
  • ✓Life expectancy >12 weeks
Key exclusion· 10
  • ✕Previously untreated NHL
  • ✕Prior clofarabine treatment
  • ✕Bulky disease defined as single mass >10 cm or circulating malignant cells ≥24,000 cells/μL
  • ✕AIDS-related or HIV-positive lymphoma

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

Search/NCT00156013
NCT00156013Phase 2Completed
CompareCT.gov

A Phase I/II Open-label Study of Clofarabine in Patients With Relapsed or Refractory Diffuse Large Cell B-Cell NHL

Oncology Specialists, S.C.·interventional·Posted Sep 12, 2005·Updated Nov 29, 2017

In Brief

A Phase 2 clinical trial evaluating CLOFARABINE for Lymphoma, B-Cell and Lymphoma, Non-Hodgkin. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. An investigational drug is one that has not been approved by the United States Food and Drug Administration (FDA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell, Lymphoma, Non-Hodgkin
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.8 years ago

Interventions

CLOFARABINEdrug

4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles