CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
CC-5013drug
Likely dose
CC-5013 10 mg orally (2 capsules) dailyAI-extracted
Key inclusion· 4
  • ✓Diagnosis of myelofibrosis or Philadelphia-negative myeloproliferative disorder with myelofibrosis requiring therapy
  • ✓Disease-free of prior malignancies for ≥2 years (except non-melanoma skin cancer or cervical/breast carcinoma in situ)
  • ✓ECOG performance status 0-3
  • ✓Total bilirubin ≤3.0 mg/dL (unless due to tumor) and serum creatinine ≤3.0 mg/dL (unless due to tumor)
Key exclusion· 5
  • ✕Experimental drug or therapy within 28 days prior (except growth factors)
  • ✕Platelet count <30,000
  • ✕Prior clinically relevant hypersensitivity reaction or desquamating rash with thalidomide
  • ✕Prior therapy with CC-5013 (lenalidomide)

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

Search/NCT00087672
NCT00087672Phase 2Completed
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Phase II Study of CC-5013 in Myelofibrosis

M.D. Anderson Cancer Center·interventional·Posted Jul 14, 2004·Updated Aug 7, 2012

In Brief

A Phase 2 clinical trial evaluating CC-5013 for Myelofibrosis. Completed, enrolled 41 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2004
Enrollment StartJul 1, 2004
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.0 years ago

Interventions

CC-5013drug

10 mg orally (2 capsules) daily