CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
filgrastim +12 morebiological
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/NCT00546377
NCT00546377Phase 2Completed

A Phase I-II Study of Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Previously Treated Patients With Chronic Lymphocytic Leukemia and Other Low Grade B-Cell Neoplasms

Memorial Sloan Kettering Cancer Center·interventional·Posted Oct 18, 2007·Updated May 12, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, pegfilgrastim, and 11 other interventions for Leukemia and Lymphoma. Completed, enrolled 50 participants across 1 site.

Detailed Summary

RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving pentostatin together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2007
Enrollment StartJul 1, 2005
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 18.7 years ago

Interventions

filgrastimbiological

pegfilgrastimbiological

rituximabbiological

sargramostimbiological

cyclophosphamidedrug

mitoxantrone hydrochloridedrug

pentostatindrug

fluorescence in situ hybridizationgenetic

gene rearrangement analysisgenetic

polymerase chain reactiongenetic

protein expression analysisgenetic

flow cytometryother

biopsyprocedure