CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
alvocidibdrug
Likely dose
alvocidib administered as a 30 minute loading dose followed by a 4-hour infusionAI-extracted
Key inclusion· 7
  • ✓Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, including Waldenström's macroglobulinemia, with evidence of disease activity (splenomegaly/lymphadenopathy, anemia, thrombocytopenia, weight loss, fatigue, fevers/night sweats, or progressive lymphocytosis)
  • ✓At least one prior therapy for CLL
  • ✓ECOG performance status 0-2
  • ✓WBC less than 200,000/mm³
Key exclusion· 7
  • ✕History of inflammatory bowel disease (Crohn's disease or ulcerative colitis) unless inactive for more than 2 years
  • ✕Other malignancy that would limit survival to less than 2 years
  • ✕Psychiatric condition that would preclude compliance with treatment or informed consent
  • ✕Concurrent chemotherapy

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

Search/NCT00058240
NCT00058240Phase 2Completed
CompareCT.gov

A Dose-Escalation Study of Flavopiridol (NSC 649890) Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

National Cancer Institute (NCI)·interventional·Posted Apr 9, 2003·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating alvocidib for B-cell Chronic Lymphocytic Leukemia and 3 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of flavopiridol in treating patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma. Drugs used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from dividing so they stop growing or die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartApr 1, 2003
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.2 years ago

Interventions

alvocidibdrug

Given IV