Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia - Full Text View

Sponsored by:	German CLL Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00281931

Purpose

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, 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 find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.

Condition	Intervention	Phase
Leukemia	Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	21
Study Start Date:	September 1999

Detailed Description:

OBJECTIVES:

Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab.
Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6.

Treatment repeats every 28 days for up to 6 courses.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of B-cell prolymphocytic leukemia
- Previously treated disease
All Binet stages allowed

PATIENT CHARACTERISTICS:

Life expectancy > 3 months
ECOG/WHO performance status 0-3

PRIOR CONCURRENT THERAPY:

No more than 3 prior treatment regimens

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281931

Locations

Germany
Helios Klinikum Erfurt
Erfurt, Germany, 99012

Sponsors and Collaborators

German CLL Study Group

Investigators

Study Chair:

Michael Herold, MD, PhD

Helios Klinikum Erfurt

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000454581, GCLLSG-PLL1, EU-20563
Study First Received:	January 24, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00281931 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

prolymphocytic leukemia

Study placed in the following topic categories:

Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Prolymphocytic Leukemia
Immunologic Factors
Rituximab
Cyclophosphamide
Fludarabine monophosphate
Immunosuppressive Agents

Leukemia
Lymphatic Diseases
Leukemia, Prolymphocytic
Antineoplastic Agents, Alkylating
Fludarabine
Antirheumatic Agents
Lymphoproliferative Disorders
Alkylating Agents

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia
Leukemia, Prolymphocytic
Therapeutic Uses
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009