Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00103558
First received: February 10, 2005
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

This is an open label, Phase I/II, dose escalation research study of an investigational product called lumiliximab, given with FDA (Food and Drug Administration) approved products fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42 months or until your disease progresses and you require additional CLL therapy. The total duration of participation in the study will be approximately 4 years, however your disease status will be followed indefinitely (forever).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Lumiliximab with FCR
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Characterize the safety profile [ Time Frame: monthly until month 12, then every 3 months for 24 months, then every 6 months until month 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the pharmacokinetics of lumiliximab and rituximab [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2004
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lumiliximab with FCR
    Dose, schedule, and duration specified in protocol
  Eligibility

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

Inclusion Criteria:

  • Age: 18 years and older
  • Diagnosis of B-cell CLL by International Workshop on CLL (IWCLL) response criteria
  • Relapsed CD23+ B-cell CLL
  • Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling or peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms
  • Prestudy WHO Performance Status less than or equal to 2
  • Signed, written Institutional Review Board (IRB)-approved informed consent
  • Men & women of reproductive potential must agree to follow accepted birth control methods during treatment for 3 months after completion of treatment
  • Acceptable liver function: Bilirubin less than or equal to 2.0 mg/dL (26 µmol/L), AST (SGOT) &/or ALT (SGPT) less than or equal to 2 times upper limit of normal
  • Acceptable hematologic status: Platelet count less than or equal to 50 x 10^9/L, ANC less than or equal to 1 x 109/L
  • Acceptable renal function: Serum creatinine less than or equal to 1.5 times upper limit of normal

Exclusion Criteria:

  • Subjects who did not respond to prior FCR therapy (relapsed within 6 months of the last dose).
  • Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1
  • Previous exposure to lumiliximab or other anti-CD23 antibodies
  • Subjects who have had a prior allogenic bone marrow transplant (BMT) or autologous BMT or peripheral stem-cell transplant (PBSCT)
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Transformation to aggressive B-cell malignancy (e.g., larger B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia (PLL)
  • Subjects with secondary malignancy requiring active treatment (except hormonal therapy)
  • Subjects with medical conditions currently requiring long-term use (less than 1 month) of systemic corticosteroids
  • Serious nonmalignant disease or laboratory abnormality, which, in the opinion of the investigator &/or sponsor, would compromise protocol objectives
  • Active uncontrolled bacteria, viral, or fungal infections
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Study Day 1
  • Seizure disorders requiring anticonvulsant therapy
  • Severe chronic obstructive pulmonary disease with hypoxemia
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
  • Clinically active autoimmune disease
  • Subjects with a history of fludarabine-induced autoimmune cytopenia
  • Pregnant or currently breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103558

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Diego, California, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Texas
Research Site
Houston, Texas, United States
Sponsors and Collaborators
Biogen Idec
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00103558     History of Changes
Other Study ID Numbers: 152-30
Study First Received: February 10, 2005
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014