Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

Sponsor

East Valley Hematology and Oncology Medical Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00131313

Collaborator

Mena, Raul, M.D. (Other), Pharmatech Oncology (Industry), Astex Pharmaceuticals, Inc. (Industry)

180

Enrollment

Locations

Duration (Months)

3.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Nipent, Cytoxan, Rituxan	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

Efficacy response rate []

Secondary Outcome Measures

Time to progression []
Time to treatment failure []
Toxicity []
Incidence and severity of adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Alabama Cancer Center, PC	Muscle Shoals	Alabama	United States	35661
2	East Valley Hematology and Oncology Medical Group	Burbank	California	United States	91505
3	Bay Area Cancer Research Group	Concord	California	United States	94520
4	Lalita Pandit, MD, Inc.	Fountain Valley	California	United States	92708
5	Pacific Coast Hematology/Oncology Medical Group, Inc.	Fountain Valley	California	United States	92708
6	Robert A. Moss, M.D. FACP, Inc.	Fountain Valley	California	United States	92708
7	Metropolitan Hematology Oncology Medical Group	Los Angeles	California	United States	90057
8	North County Oncology	Oceanside	California	United States	92056
9	Ventura County Hematology Oncology Specialists	Oxnard	California	United States	93030
10	Cancer and Blood Institute Medical Group	Rancho Mirage	California	United States	92270
11	St. Teresa Comprehensive Cancer Center	Stockton	California	United States	95207
12	Medical Group of North County	Vista	California	United States	92081
13	The Oncology Clinic, PC	Colorado Springs	Colorado	United States	80907
14	Mile High Oncology	Denver	Colorado	United States	80210
15	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida	United States	33435
16	Integrated Community Oncology Network	Jacksonville	Florida	United States	32256
17	Osceola Cancer Center	Kissimmee	Florida	United States	34741
18	Pasco Hernando Oncology Associates, PA	New Port Richey	Florida	United States	34642
19	Pasco Pinellas Cancer Center	New Port Richey	Florida	United States	34652
20	Augusta Oncology Associates, PC	Augusta	Georgia	United States	30901
21	Spalding Oncology Services	Griffin	Georgia	United States	30224
22	St Luke's Mountain States Tumor Institute	Boise	Idaho	United States	83712
23	Oncology Hematology Assoc. of Northern Illinois	Gurnee	Illinois	United States	60031
24	Indiana Oncology Hematology Consultants	Indianapolis	Indiana	United States	46202
25	Arnett Cancer Care	Lafayette	Indiana	United States	47904
26	Cancer Care Center	New Albany	Indiana	United States	47150
27	Kentucky Cancer Clinic	Hazard	Kentucky	United States	41701
28	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
29	Chesapeake Oncology Hematology Associates	Baltimore	Maryland	United States	21225
30	Auerbach Hematology Oncology Associates, Inc.	Baltimore	Maryland	United States	21237
31	Genesee Cancer & Blood Disease Treatment Center, PC	Flint	Michigan	United States	48503
32	West Michigan Regional Cancer & Blood Center	Freesoil	Michigan	United States	49411
33	Spectrum Health Hospitals	Grand Rapids	Michigan	United States	49503
34	Branson Oncology Clinic	Branson	Missouri	United States	65616
35	St. Louis Hematology Oncology Specialists, Inc.	St. Louis	Missouri	United States	63117
36	Sierra Nevada Oncology Care	Carson City	Nevada	United States	89703
37	Nevada Cancer Center	Las Vegas	Nevada	United States	89109
38	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey	United States	08003
39	Ellioth Fishkin, MD	Elizabeth	New Jersey	United States	07201
40	Westchester Hematology Oncology Associates	Mount Kisco	New York	United States	10549
41	Mid Dakota Clinic/Odyssey Research	Bismarck	North Dakota	United States	58501
42	Summa Health System Hospitals	Akron	Ohio	United States	44304
43	Nashat Y. Gabrail, MD, Inc.	Canton	Ohio	United States	44718
44	Sambandam and Joseph Associates, Inc	Cranston	Rhode Island	United States	02920
45	Charleston Hematology Oncology, PA	Charleston	South Carolina	United States	29403
46	South Carolina Oncology Associates	Columbia	South Carolina	United States	29210
47	The Family Cancer Center	Collierville	Tennessee	United States	38017
48	C. Michael Jones, MD, PC	Germantown	Tennessee	United States	38138
49	JPS Center for Cancer Care	Fort Worth	Texas	United States	76104
50	Cache Valley Cancer Treatment & Research Clinic, Inc.	Logan	Utah	United States	84341
51	Cancer Outreach Associates, PC	Abingdon	Virginia	United States	24211
52	Virginia Oncology Care, PC	Richlands	Virginia	United States	24641