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A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.


Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S.
Recent experience with Nipent in conjunction with Rituxan has shown that this combination is
well tolerated and is clinically promising. It is expected that the addition of Cytoxan in
patients with previously untreated CLL and patients who have relapsed or failed prior
therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown
how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent
regimen, however, patients will be monitored for toxicities. It is expected that bone marrow
toxicities will not increase to unreasonable levels.

The primary objective of the study is to determine the overall efficacy response rate
following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated
or treated CLL. The secondary objectives of the study are to determine the duration of
response, time to progression, time to treatment failure and to evaluate the toxicity of
this combination of drugs and the incidence and severity of adverse events.


Inclusion Criteria:



- Stage II, III or IV Chronic Lymphocytic Leukemia

- Disease requires chemotherapeutic treatment

- CT or MRI scan confirming measurable tumor size

- Documentation of CD markers

- Up to one prior treatment regimen

- Expected survival greater than 6 months

- ECOG performance status of 0-2

- Adequate renal, bone marrow and liver functions

- Negative pregnancy test (females of childbearing potential)

- Must agree to use acceptable birth control, if fertile

- Must complete Informed Consent

- No heart disease and must have adequate cardiac function

- Must test negative for viral Hepatitis B and C

Exclusion Criteria:

- More than one prior treatment for Chronic Lymphocytic Leukemia

- Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs

- Known HIV or AIDS illness

- Thyroid disease requiring medication

- History of any malignancy that could affect the diagnosis or assessment of the study
treatment

- Pregnancy or breast feeding

- Evidence of Hepatitis B or C infection

- Inability to comply with the requirements of the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy response rate

Principal Investigator

Raul Mena, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

East Valley Hematology and Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

POI-02818

NCT ID:

NCT00131313

Start Date:

January 2003

Completion Date:

April 2009

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Cancer
  • Nipent
  • Rituxan
  • Cytoxan
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Nevada Cancer CenterLas Vegas, Nevada  89109
Cancer Care CenterNew Albany, Indiana  47150
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Osceola Cancer CenterKissimmee, Florida  34741
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Medical Group of North CountyVista, California  92083
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
Bay Area Cancer Research GroupConcord, California  94520
Pacific Coast Hematology/Oncology Medical Group, Inc.Fountain Valley, California  92708
Nashat Y. Gabrail, MD, Inc.Canton, Ohio  44718
Arnett Cancer CareLafayette, Indiana  47904
Kentucky Cancer ClinicPikeville, Kentucky  41501
Mile High OncologyDenver, Colorado  80210
Indiana Oncology Hematology ConsultantsIndianapolis, Indiana  46202
The Family Cancer CenterCollierville, Tennessee  38017
Spalding Oncology ServicesGriffin, Georgia  30224
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Cancer and Blood Institute Medical GroupRancho Mirage, California  92270
West Michigan Regional Cancer & Blood CenterFree Soil, Michigan  49411
Westchester Hematology Oncology AssociatesMount Kisco, New York  10549
Ventura County Hematology Oncology SpecialistsOxnard, California  93030
Palm Beach Institute of Hematology and OncologyBoynton Beach, Florida  33435
JPS Center for Cancer CareFort Worth, Texas  76104
Sierra Nevada Oncology CareCarson City, Nevada  89703
Cancer Outreach Associates, PCAbingdon, Virginia  24211
Northwest Alabama Cancer Center, PCFlorence, Alabama  35630
East Valley Hematology and Oncology Medical GroupBurbank, California  91505
Lalita Pandit, MD, Inc.Fountain Valley, California  92708
Robert A. Moss, M.D. FACP, Inc.Fountain Valley, California  92708
Metropolitan Hematology Oncology Medical GroupLos Angeles, California  90057
North County OncologyOceanside, California  92056
St. Teresa Comprehensive Cancer CenterStockton, California  95207
The Oncology Clinic, PCColorado Springs, Colorado  80907
Pasco Hernando Oncology Associates, PANew Port Richey, Florida  34642
Augusta Oncology Associates, PCAugusta, Georgia  30901
St Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Oncology Hematology Assoc. of Northern IllinoisGurnee, Illinois  60031
Auerbach Hematology Oncology Associates, Inc.Baltimore, Maryland  21237
Chesapeake Oncology Hematology AssociatesBaltimore, Maryland  21225
Genesee Cancer & Blood Disease Treatment Center, PCFlint, Michigan  48503
Spectrum Health HospitalsGrand Rapids, Michigan  49503
Branson Oncology ClinicBranson, Missouri  65616
St. Louis Hematology Oncology Specialists, Inc.St. Louis, Missouri  63117
Ellioth Fishkin, MDElizabeth, New Jersey  07201
Mid Dakota Clinic/Odyssey ResearchBismarck, North Dakota  58501
Summa Health System HospitalsAkron, Ohio  44304
Sambandam and Joseph Associates, IncCranston, Rhode Island  02920
C. Michael Jones, MD, PCGermantown, Tennessee  38138
Cache Valley Cancer Treatment & Research Clinic, Inc.Logan, Utah  84341
Virginia Oncology Care, PCRichlands, Virginia  24641