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Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer

NCT00546377 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-05-12

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

pegfilgrastim

BIOLOGICAL

rituximab

BIOLOGICAL

sargramostim

DRUG

cyclophosphamide

DRUG

mitoxantrone hydrochloride

DRUG

pentostatin

GENETIC

fluorescence in situ hybridization

GENETIC

gene rearrangement analysis

GENETIC

polymerase chain reaction

GENETIC

protein expression analysis

OTHER

flow cytometry

PROCEDURE

biopsy

Sponsors & Collaborators

Principal Investigators

  • Renier Brentjens, MD, PhD · Memorial Sloan Kettering Cancer Center

  • Andrew D. Zelenetz, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546377 on ClinicalTrials.gov