Clinical trial NCT00131313: Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
Official title: A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Lymphocytic Leukemia
Keywords: Leukemia
Cancer
Nipent
Rituxan
Cytoxan
Lead sponsor: East Valley Hematology and Oncology Medical Group
Sponsor class: OTHER
Collaborators: name: Mena, Raul, M.D.
name: Pharmatech Oncology
name: Astex Pharmaceuticals, Inc.
First posted: 2005-08-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy response rate
Secondary outcomes:
measure: Time to progression
measure: Time to treatment failure
measure: Toxicity
measure: Incidence and severity of adverse events
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, PC
state: Alabama
city: Burbank
country: United States
facility: East Valley Hematology and Oncology Medical Group
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fountain Valley
country: United States
facility: Lalita Pandit, MD, Inc.
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Robert A. Moss, M.D. FACP, Inc.
state: California
city: Los Angeles
country: United States
facility: Metropolitan Hematology Oncology Medical Group
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Rancho Mirage
country: United States
facility: Cancer and Blood Institute Medical Group
state: California
city: Stockton
country: United States
facility: St. Teresa Comprehensive Cancer Center
state: California
city: Vista
country: United States
facility: Medical Group of North County
state: California
city: Colorado Springs
country: United States
facility: The Oncology Clinic, PC
state: Colorado
city: Denver
country: United States
facility: Mile High Oncology
state: Colorado
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associates, PA
state: Florida
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC
state: Georgia
city: Griffin
country: United States
facility: Spalding Oncology Services
state: Georgia
city: Boise
country: United States
facility: St Luke's Mountain States Tumor Institute
state: Idaho
city: Gurnee
country: United States
facility: Oncology Hematology Assoc. of Northern Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Oncology Hematology Associates
state: Maryland
city: Baltimore
country: United States
facility: Auerbach Hematology Oncology Associates, Inc.
state: Maryland
city: Flint
country: United States
facility: Genesee Cancer & Blood Disease Treatment Center, PC
state: Michigan
city: Freesoil
country: United States
facility: West Michigan Regional Cancer & Blood Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Branson
country: United States
facility: Branson Oncology Clinic
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Hematology Oncology Specialists, Inc.
state: Missouri
city: Carson City
country: United States
facility: Sierra Nevada Oncology Care
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Elizabeth
country: United States
facility: Ellioth Fishkin, MD
state: New Jersey
city: Mount Kisco
country: United States
facility: Westchester Hematology Oncology Associates
state: New York
city: Bismarck
country: United States
facility: Mid Dakota Clinic/Odyssey Research
state: North Dakota
city: Akron
country: United States
facility: Summa Health System Hospitals
state: Ohio
city: Canton
country: United States
facility: Nashat Y. Gabrail, MD, Inc.
state: Ohio
city: Cranston
country: United States
facility: Sambandam and Joseph Associates, Inc
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Germantown
country: United States
facility: C. Michael Jones, MD, PC
state: Tennessee
city: Fort Worth
country: United States
facility: JPS Center for Cancer Care
state: Texas
city: Logan
country: United States
facility: Cache Valley Cancer Treatment & Research Clinic, Inc.
state: Utah
city: Abingdon
country: United States
facility: Cancer Outreach Associates, PC
state: Virginia
city: Richlands
country: United States
facility: Virginia Oncology Care, PC
state: Virginia
Study officials:
affiliation: East Valley Hematology and Oncology Group
name: Raul Mena, MD
role: PRINCIPAL_INVESTIGATOR
References: