- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183989
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
May 20, 2014 updated by: University of Southern California
A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma.
All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma.
Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma.
The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90033
- Norris Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
- Newly diagnosed and patients who have received prior treatment are eligible
- Measurable or evaluable disease
- Karnofsky performance status greater or equal to 50%
- Men and women, age greater or equal to 18 years old
- AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
- Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
- Women of child bearing potential must have negative pregnancy test within 14 days of study entry.
- Signed informed consent
Exclusion Criteria:
- History of congestive heart failure or significant cardiac disease
- Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab allowed
- Active infection
- HIV seropositive
- Pregnant or lactating females
- Second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
- Presence of psychological or emotional disorders which would make valid informed consent impossible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexandra M. Levine, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
May 22, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Rituximab
- Fludarabine
- Mitoxantrone
Other Study ID Numbers
- 13NHL-99-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mantle Cell Lymphoma
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Northwestern UniversityNational Cancer Institute (NCI); Janssen Scientific Affairs, LLCActive, not recruitingStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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National Cancer Institute (NCI)CompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Stage I Mantle Cell Lymphoma | Stage II Contiguous Mantle Cell Lymphoma | Stage II Non-Contiguous Mantle Cell LymphomaUnited States
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Burzynski Research InstituteWithdrawnRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell LymphomaUnited States
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University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma | Ann Arbor Stage I Mantle Cell Lymphoma | Ann Arbor Stage II Mantle Cell Lymphoma | Ann Arbor Stage III Mantle Cell Lymphoma | Ann Arbor Stage IV Mantle Cell LymphomaUnited States
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BeiGeneRecruitingMantle Cell Lymphoma | Relapsed Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma (MCL)United States, China, Israel, Belgium, Poland, Spain, Turkey, Brazil, Italy, Canada, United Kingdom, France, Germany, Argentina, Puerto Rico
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BeiGeneCompletedRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaChina
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Fondazione Italiana Linfomi - ETSRecruitingRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaItaly
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Mantle Cell Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Refractory Mantle Cell Lymphoma | Central Nervous System Lymphoma | Gastric Mantle Cell Lymphoma | Splenic Mantle Cell LymphomaUnited States
Clinical Trials on Fludarabine, Mitoxantrone and Rituximab
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Lymphoma Study AssociationCompleted
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Cancer Research UKCompleted
-
Emory UniversityBayerTerminated
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Millennium Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development, L.L.C.TerminatedFollicular LymphomaItaly, Israel, Germany, France, Greece, Spain, Switzerland
-
Genta IncorporatedCompletedChronic Lymphocytic LeukemiaUnited States
-
CTI BioPharmaWithdrawnNon-Hodgkin's LymphomaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)TerminatedLeukemiaUnited States, Canada
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedLymphomaUnited States, Canada, United Kingdom, Sweden
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BayerCompleted