Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) (LUCID)

This study has been terminated.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00391066
First received: October 19, 2006
Last updated: September 12, 2013
Last verified: April 2011
  Purpose

This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: FCR + Lumiliximab
Drug: FCR
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Complete Response (CR) rate [ Time Frame: Every 3 months until all patients have reached at least week 33 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival) [ Time Frame: Every 3 months until all patients have reached at least week 33 ] [ Designated as safety issue: No ]
  • Response variables [ Time Frame: Every 3 months until all patients have reached at least week 33 ] [ Designated as safety issue: No ]

Enrollment: 627
Study Start Date: November 2006
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

FCR

F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks

C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks

R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks

Drug: FCR
Dose, schedule, and duration specified in protocol
Experimental: 2

FCR + Lumiliximab (L)

L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks.

F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks

C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks

R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks

Drug: FCR + Lumiliximab
Dose, schedule, and duration specified in the protocol

  Eligibility

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

Inclusion Criteria:

  • Signed, written EC-approved informed consent form.
  • Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by NCI WG guidelines.
  • Subjects who have received at least 1 but no more than 2 prior single agent or combination treatments for CLL.
  • Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Criteria - Modified Rai).
  • WHO Performance Status less than or equal to 2.
  • Age greater than or equal to 18 years.
  • Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
  • Acceptable liver function: bilirubin less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal.
  • Acceptable hematologic status: platelet count greater than or equal to 50 x 10^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10^9/L.
  • Acceptable renal function: creatinine clearance calculated according to the formula of Cockcroft and Gault >50 mL/min; serum creatinine less than or equal to 1.5 times upper limit of normal.

Exclusion Criteria:

  • Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues include fludarabine, pentostatin and cladribine.
  • 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.
  • Prior autologous or allogeneic BMT or hematopoetic stem cell transplant.
  • Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.
  • Uncontrolled diabetes mellitus.
  • Uncontrolled hypertension.
  • Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter's Syndrome, or PLL).
  • Secondary malignancy requiring active treatment (except hormonal therapy).
  • Any medical condition that would require long-term use (>1 month) of systemic corticosteroids during study treatment. However, steroid use less than or equal to 1 month is permissible during the study.
  • Any serious nonmalignant disease or laboratory abnormality, which in the opinion of the Investigator and/or Sponsor would compromise protocol objectives.
  • Active uncontrolled bacterial, 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 30 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.
  • History of fludarabine-induced autoimmune cytopenia (as judged by the Investigator) or Coombs-positive haemolytic anemia.
  • Pregnant or currently breastfeeding.
  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: NCT00391066

  Show 192 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

Publications:
Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00391066     History of Changes
Other Study ID Numbers: 152CL201
Study First Received: October 19, 2006
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
CD23+/CD20+ B-cell CLL
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014