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Study Looking to See How Effective Fludarabine and Rituximab Followed by Bexxar Are for CLL or SLL
This study is currently recruiting participants.
Verified by Fred Hutchinson Cancer Research Center, October 2008
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
GlaxoSmithKline
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00476047
  Purpose

This study is evaluating the use of radioimmunotherapy (Bexxar®) given in addition to chemotherapy (Fludarabine and Rituximab) to try and eliminate any remaining disease and to lower the chance of the CLL from returning. Radioimmunotherapy uses an antibody that is designed to target specific cancer cells such as the CLL cells, and deliver a small targeted dose of radiation to them. In this study we will gather more information about the safety and effectiveness of combining standard therapy, fludarabine and rituximab, with radiolabeled antibody therapy, 131I-tositumomab, also called Bexxar®.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Fludarabine
Drug: Rituximab
Drug: 131TOSITUMOMAB (BEXXAR®)
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Fludarabine Fludarabine monophosphate Rituximab Tositumomab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of 131-Tositumomab (Bexxar) Consolidation In Patients With B-Cell Chronic Lymphocytic Leukemia Following Fludarabine and Rituximab Chemotherapy

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Estimate the progression-free survival at 2 years after completing 6 cycles of Fludarabine and Rituximab followed by 131 I-Tositumomab (Bexxar) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To eliminate residual disease (documented by flow cytometry or PCR) using 131 I-Tositumomab (Bexxar) in patients who have achieved a complete response to 6 cycles of Fludarabine and Rituximab [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To assess response rates in those patients who did not achieve a complete response after 6 cycles of Fludarabine and Rituximab [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Evaluate the toxicities of Fludarabine and Rituximab followed by 131 I-Tositumomab (Bexxar) in patients with newly diagnosed CLL or SLL. [ Time Frame: 2-10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2007
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fludarabine
    Fludarabine IV (25 mg/m2) days 1 thru 5 every 5 weeks for 6 cycles
    Drug: Rituximab
    Rituximab IV (375 mg/m2) days 4 or 5 every 5 weeks for 6 cycles
    Drug: 131TOSITUMOMAB (BEXXAR®)
    75 or 65 cGY between day 90 and day 120 (from first day of cycle 6 of Fludarabine and Rituximab) platelet count will determine dose (65 or 75 CGY)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with previously untreated CD20+ CLL/SLL must have either Rai stage III/IV disease or be Rai stage I/II with evidence of disease activity as defined by the NCI 1996 guidelines
  • Patient must be age 18 or older.
  • Patient must have a ECOG performance status of 0, 1 or 2
  • Patient must have an anticipated (untreated) survival of at least 3 months.
  • Patient must have adequate:
  • Bone Marrow Function: ANC ≥ 1,000/µL, platelets ≥ 75,000/µL.
  • Renal Function: serum creatinine <2 times upper limit of normal.
  • Hepatic function: total bilirubin <2 times upper limit of normal, AST <5 times upper limit of normal.
  • Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving I-131 labeled tositumomab.

Exclusion Criteria:

  • Patients who have received prior radiolabeled antibody.
  • Patients with active hemolysis.
  • Patients must not require sustained transfusion support of blood products.
  • Patients who have received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment prior to study entry. Patients who have received systemic steroids within 1 week of study entry are excluded, except patients on maintenance steroid therapy for a non-cancerous disease.
  • Patients who have undergone treatment with either stem cell or bone marrow transplant.
  • Patients with active obstructive hydronephrosis.
  • Patients with evidence of any significant systemic illness, active Hepatitis B infection or other active infection at the time of study entry.
  • Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
  • Patients with known HIV infection.
  • Patients who are pregnant or nursing.
  • Patients with prior malignancy other than CLL/SLL, except for adequately-treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years unless approved by the PI.
  • Patients with known brain or leptomeningeal involvement by malignancy.
  • Patients who have, in the opinion of the investigator, other medical, social, or psychosocial factors that may negatively impact compliance or their safety by participation in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476047

Contacts
Contact: Britt E Kammerer, CCRC 206-667-4174 bkammere@fhcrc.org
Contact: Wendy A Wilson, RN, OCN 206-667-4195 wwilson@fhcrc.org

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: John M Pagel, MD, PhD            
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
GlaxoSmithKline
Investigators
Principal Investigator: John M. Pagel, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Fred Hutchinson Cancer Research Center Clinical Trial Search  This link exits the ClinicalTrials.gov site

Responsible Party: Fred Hutchinson Cancer Research Center ( John M. Pagel, MD PhD )
Study ID Numbers: PSOC 2301, IR-6466
Study First Received: May 17, 2007
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00476047  
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Leukemia, Lymphocytic, Chronic, B Cell
Lymphocytic Leukemia, Chronic, B Cell
B Cell Leukemia, Chronic
B Lymphocytic Leukemia, Chronic
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Leukemia
Lymphoma
CLL
SLL
Fludarabine
Fludara
Rituximab
Rituxan
Tositumomab
Bexxar
Initial therapy
First line therapy

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Iodine-131 anti-B1 antibody
Fludarabine monophosphate
Leukemia
Lymphatic Diseases
Antibodies
Leukemia, Lymphocytic, Chronic, B-Cell
Iodine
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009