Chronic Lymphocytic LeukemiaPhase 2LUCIDNCT00391066
Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing FCR + Lumiliximab and FCR in people with Chronic Lymphocytic Leukemia, run by Biogen at 194 sites in 23 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- FCR + Lumiliximab and FCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 194 sitesin 23 countries
- Study dates
- Nov 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
194 sites in 23 countries.
194 sites in 23 countries
United States53 sites
Research Site
Alhambra, California
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
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Bedford, Texas
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Billings, Montana
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Boston, Massachusetts
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Burbank, California
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Chapel Hill, North Carolina
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Chicago, Illinois
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Columbia, Missouri
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Columbus, Ohio
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Dallas, Texas
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Detroit, Michigan
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Fort Myers, Florida
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Fort Worth, Texas
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Fredericksburg, Texas
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Fullerton, California
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Greenville, South Carolina
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Hackensack, New Jersey
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Houston, Texas
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Indianapolis, Indiana
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Kennewick, Washington
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Kettering, Ohio
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La Jolla, California
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Long Beach, California
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Los Angeles, California
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Marietta, Georgia
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Maywood, Illinois
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Minneapolis, Minnesota
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Morristown, New Jersey
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Nashville, Tennessee
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Norfolk, Virginia
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Northridge, California
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Omaha, Nebraska
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Overland Park, Kansas
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Oxnard, California
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Pomona, California
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Raleigh, North Carolina
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Redondo Beach, California
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Roanoke, Virginia
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Sacramento, California
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Saint Joseph, Michigan
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Saint Louis, Washington
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San Antonio, Texas
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Santa Maria, California
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Scottsdale, Arizona
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Shreveport, Louisiana
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Spokane, Washington
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St Louis, Missouri
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Yakima, Washington
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Ypsilant,, Michigan
Australia22 sites
Research Site
Adelaide, South Australia, 5000
Research Site
Adelaide, South Australia
Research Site
Ashford, South Australia
Research Site
Box Hill, Victoria, 3128
Research Site
Clayton, Victoria, 3168
Research Site
Clayton, Victoria
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Darlinghurst, New South Wales
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East Melbourne, Victoria
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Fitzroy, Victoria, 3065
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Freemantle, Western Australia
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Gosford, New South Wales
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Greenslopes, Queensland, 4120
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Herston, Queensland
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Melbourne
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Nedlands, Western Australia
Research Site
Perth, Western Australia
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South Brisbane, Queensland
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St Leonards, New South Wales
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Waratah, New South Wales
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Westmead, New South Wales
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Woodville, South Australia
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Woolloongabba, Queensland
United Kingdom12 sites
Research Site
Bath
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Belfast
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Birmingham
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Bournemouth
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Edinburgh
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Glasgow
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Leeds
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London
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Manchester
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Plymouth
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Surrey
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Taunton
France11 sites
Research Site
Angers
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Bordeaux
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Le Mans
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Lille
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Limoges
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Nantes
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Nice
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Pessac
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Rennes
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Rouen
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Tours
Canada8 sites
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Calgary, Alberta
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Edmonton, Alberta
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Halifax, Nova Scotia
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Hamilton
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London, Ontario
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Montreal, Quebec
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Québec
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Toronto, Ontario
India8 sites
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Ahmedabad
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Bangalore
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Delhi
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Mumbai
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Nashik
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New Delhi
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Pune
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Trivandrum
Russia8 sites
Research Site
Nizhny Novgorod
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Obninsk
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Ryazan
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Saint Peterburg
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Saint Petersburg
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Samara
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Saratov
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Yekaterinburg
Belgium7 sites
Research Site
Antwerp
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Bruges
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Brussels
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Edegem
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Ghent
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Herestraat
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Yvoir
Poland7 sites
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Bialystok
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Gdansk
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Katowice
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Krakow
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Lodz
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Szczecin
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Warsaw
Germany6 sites
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Augsburg
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Dessau
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Frankfurt
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Greifswald
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Kiel
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Würzburg
Israel6 sites
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Ashkelon
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Haifa
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Jerusalem
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Petah Tikva
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Ramat Gan
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Rehovo
Italy6 sites
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Milan
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Novara
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Roma
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Rome
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Rozzano
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Verona
Portugal6 sites
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Almada
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Braga
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Coimbra
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Lisbon
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Porto
Research Site
Viseu
Spain6 sites
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Madrid
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Murcia
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Palma de Mallorca
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Salamanca
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Toledo
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Zaragoza
Brazil5 sites
Research Site
Goiania - GO
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Porto Alegre
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Rio de Janeiro
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Santo André
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São Paulo
New Zealand5 sites
Research Site
Auckland
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Christchurch
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Hamilton
Research Site
Palmerston North
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Wellington
Austria4 sites
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Graz
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Innsbruck
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Salzburg
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Vienna
Czechia3 sites
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Brno
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Hradec Králové
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Prague
Slovakia3 sites
Research Site
Banská Bystrica
Research Site
Bratislava
Research Site
Martin
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- FCR + Lumiliximab, FCR
- Keywords
- CD23+/CD20+ B-cell CLL, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCR + LumiliximabDrug
Dose, schedule, and duration specified in the protocol
FCRDrug
Dose, schedule, and duration specified in protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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 Receives: Drug: FCR |
| 2 | Experimental | 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 Receives: Drug: FCR + Lumiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate
Measured: Every 3 months until all patients have reached at least week 33
Secondary outcomes (2)
Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival)
Measured: Every 3 months until all patients have reached at least week 33
Response variables
Measured: Every 3 months until all patients have reached at least week 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391066
- Sponsor's protocol ID
- 152CL201
- Acronym
- LUCID
- Status last verified
- Apr 2011
- First submitted
- 19 Oct 2006
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.
PubMed 19843887Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.
PubMed 18032710Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.
PubMed 17671129Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 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 leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.
PubMed 25130401
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00391066
- Acronym / sponsor ID
- LUCID / 152CL201
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CD23+/CD20+ B-cell CLL, CLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 627 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: FCRFCR 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 |
| 2 | Experimental | Drug: FCR + LumiliximabFCR + 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCR + LumiliximabDose, schedule, and duration specified in the protocol | Drug | 2 |
| FCRDose, schedule, and duration specified in protocol | Drug | 1 |
Primary outcome
Complete Response (CR) rate
Time frame: Every 3 months until all patients have reached at least week 33
2 secondary outcomes
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
Response variables
Time frame: Every 3 months until all patients have reached at least week 33
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Background: PubMed 19843887Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.
- Background: PubMed 18032710Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.
- Background: PubMed 17671129Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.
- Derived from this study: PubMed 25130401Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 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 leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
194 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FCR + Lumiliximab and FCR in people with Chronic Lymphocytic Leukemia, run by Biogen at 194 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 194 sites in United States, Australia, United Kingdom, France, Canada and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate (time frame: Every 3 months until all patients have reached at least week 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391066, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.