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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00546377
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • pegfilgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • sargramostim — BIOLOGICAL
  • cyclophosphamide — DRUG
  • mitoxantrone hydrochloride — DRUG
  • pentostatin — DRUG
  • fluorescence in situ hybridization — GENETIC
  • gene rearrangement analysis — GENETIC
  • polymerase chain reaction — GENETIC
  • protein expression analysis — GENETIC
  • flow cytometry — OTHER
  • biopsy — PROCEDURE

Study Details

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.

Key Dates

Start date
Jul 31, 2005
Status verified
Apr 2016
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mitoxantrone

Primary Outcome Measure

Overall Response [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition

Related Studies