Chronic Lymphocytic LeukemiaPhase 3NCT00090051
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
A Phase 3 study testing Rituximab, Fludarabine Phosphate and Cyclophosphamide in people with Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 106 sites in 17 countries.
Trial summary
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. 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?
- Rituximab, Fludarabine Phosphate and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 106 sitesin 17 countries
- Study dates
- 31 Jul 2003to 31 May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Established diagnosis of B-cell CLL by NCI Working Group criteria
- ≤1 previous line of chemotherapy
- Expected survival >6 months
- Acceptable hematologic status, liver function, renal function, and pulmonary function
- Negative serum pregnancy test for both pre-menopausal women and for women who are < 2 years after the onset of menopause
- Written informed consent
Who cannot join
- Prior treatment with interferon, rituximab or other monoclonal antibody
- Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician
- Fertile men or women of childbearing potential not using adequate contraception
- Severe Grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen
- History of fludarabine-induced or clinically significant autoimmune cytopenia
- History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent.
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- Medical conditions requiring long term use (> 1 month) of systemic corticosteroids
- Active bacterial, viral, or fungal infection requiring systemic therapy
- Severe cardiac disease
- Seizure disorders requiring anticonvulsant therapy
- Severe chronic obstructive pulmonary disease with hypoxemia
- Uncontrolled diabetes mellitus or hypertension
- Transformation to aggressive B-cell malignancy.
- Known infection with HIV, HCV, or hepatitis B
- Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
- Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Trial locations and contacts
106 sites in 17 countries.
106 sites in 17 countries
France19 sites
Hopital Avicenne; Hematologie Biologique
Bobigny, 93009
Hopital Clemenceau; Hematologie Clinique
Caen, 14033
Chu Estaing; Hematologie Clinique Adultes
Clermont-Ferrand, 63003
Hopital Henri Mondor; Hematologie Clinique
Créteil, 94010
Clinique Victor Hugo; Chimiotherapie
Le Mans, 72015
Hopital Claude Huriez; Hematologie
Lille, 59037
Hopital Edouard Herriot; Bat.E-Hematologie
Lyon, 69003
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Institut J Paolii Calmettes; Onco Hematologie 1
Marseille, 13273
Hôpital Lapeyronie; Hématologie Oncologie Médicale
Montpellier, 34295
Hopital Hotel Dieu Et Hme;Hopital De Jour
Nantes, 44093
Hotel Dieu; Hematologie- Oncologie
Paris, 75181
Inserm Cic 9504
Paris, 75475
Hopital Pitie Salpetriere; Hematologie Clinique
Paris, 75651
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre-Bénite, 69495
Chu La Miletrie; Hdj Cons Hemato Cancerologie
Poitiers, 86021
Centre Henri Becquerel; Hematologie
Rouen, 76038
Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
Tours, 37044
Hopitaux De Brabois; Hematologie Medecine Interne
Vandœuvre-lès-Nancy, 54511
Italy10 sites
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
Naples, Campania, 80131
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100
Ospedale S. Eugenio; Divisione Di Ematologia
Rome, Lazio, 00144
Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
Rome, Lazio, 00152
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Rome, Lazio, 00161
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Apulia, 71013
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto, 36100
Russia10 sites
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, 115478
Haematology Research Center; Haematology
Moscow, 125167
City Clinical Botkin's Hospital; City Hematological Center
Moscow, 125284
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
Obninsk, 249036
Research Inst. Hematology /Blood Transfusion ; Hemablastosis, Supression Hemopoesis & B M Transplant
Saint Petersburg, 193024
Regional Clinical Hospital; Hematology Dept. #2 For B M Transplantation & High Dose Chemo.
Saint Petersburg, 194291
Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
Saint Petersburg, 197022
S.-Peterburg Pavlov State Medical University ; Haematology
Saint Petersburg, 197022
State Medical Inst. Municipal Hospital #31; Oncology & Hematology Dept. With the Usechemo. in Adult
Saint Petersburg, 197110
Regional Clinical Hospital N.A. Kalinin; Hematology Dept
Samara, 443095
United Kingdom10 sites
Royal Bournemouth General Hospital; Haematology
Bournemouth, BH7 7DW
Addenbrookes Hospital; Haematology
Cambridge, CB2 0QQ
Stobhill Hospital; Dept of Haematology
Glasgow, G83 8NG
Leeds General Infirmary; Medicine
Leeds, LS1 3EX
Leicester Royal Infirmary; Dept of Haematology
Leicester, LE1 5WW
Royal Liverpool Uni Hospital; Haematology
Liverpool, L7 8XP
St. Bartholomew'S Hospital; Dept of Medical Oncology
London, EC1A 7BE
King'S College Hospital; Haematology
London, SE5 9RS
Royal Marsden Hospital; Academic Dept of Haematology
Sutton, SW3 6JJ
Pinderfields General Hospital; Dept of Haematology
Wakefield, WF1 4DG
Canada9 sites
Uni of Alberta Hospital
Edmonton, Alberta, T6G 2R7
QEII HSC; Oncology
Halifax, Nova Scotia, B3H 2Y9
Hamilton Health Sciences - Juravinski Cancer Centre; Hematology
Hamilton, Ontario, L8V 5C2
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1
The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704
Ottawa, Ontario, K1H 1C4
Health Science Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Hungary7 sites
Szent Laszlo Hospital; Hematology Dept
Budapest, 1097
National Institute of Oncology, A Dept of Internal Medicine
Budapest, 1122
Országos Gyógyintézeti Központ; Haematologiai Osztaly
Budapest, 1135
Uni of Debrecen; 2Nd Clinic of Internal Medicine
Debrecen, 4004
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
Debrecen, 4032
Uni of Pecs; Dept of Internal Medicine
Pécs, 7624
University of Szeged, II Dept of Internal Medicine
Szeged, 6720
United States6 sites
Uab Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Rush-Presbyterian St. Luke'S Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
California Cancer Center Woodward Park; Community Medical Centers
Fresno, California, 93720
Milton S. Hershey Medical Center; Penn State Cancer Inst.
Hershey, Pennsylvania, 17033
Poland6 sites
Medical University School; Dept. of Haematology
Lodz, 93-510
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, 20-081
Akademii Medycznej W; Klinika Hematologii
Poznan, 02-097
Klin. Chorob Wewnetrznych I Hemat. Z Osrodkiem Transplant. Szpiku
Warsaw, 00-909
Instytut Hematologii I Transfuzjologii; Klinika Chorob Wewnetrznych I Hematologii
Warsaw, 00-957
Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.
Warsaw, 02-097
Spain5 sites
Hospital Universitario de la Princesa; Servicio de Hematologia
Madrid, 28006
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, 28041
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca, 37007
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, 50009
Australia4 sites
Mater Hospital; Division of Cancer Services
Brisbane, Queensland, 4101
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, 3199
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000
Concord Repatriation General Hospital; Haematology
Sydney, New South Wales, 2139
Netherlands4 sites
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
Amersfoort, 3818 ES
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, 1105 AZ
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Rotterdam, 3075 EA
Leyenburg Ziekenhuis; Haematology
The Hague, 2545 CG
Romania4 sites
Fundeni Clinical Inst. ; Hematology Dept
Bucharest, 022328
Spitalul Clinic Coltea; Clinica de Hematologie
Bucharest, 030171
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
Târgu Mureş, 540136
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
Timișoara, 300079
Belgium3 sites
ZNA Stuivenberg
Antwerp, 2060
Institut Jules Bordet
Brussels, 1000
UZ Leuven Gasthuisberg
Leuven, 3000
New Zealand3 sites
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, 1023
Christchurch Hospital; Canterbury Health Laboratories
Christchurch
Wellington Hospital; Regional Oncology Unit
Wellington, 6002
Denmark2 sites
Aarhus Universitetshospital, Hæmatologisk Afdeling R
Aarhus, 8000
Righospitalet, Hæmatologisk Klinik
København Ø, 2100
Norway2 sites
Haukeland Universitetshospital; Medicine Dept
Bergen, 5021
Rikshospitalet Uni Hospital
Oslo, 0027
Sweden2 sites
Karolinska Inst. , Huddinge Uni Hospital; Depart. of Hematology
Huddinge, 14186
Universitetssjukhuset i Linköping, Hematologkliniken
Linköping, 581 85
About this study
Official title: Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Rituximab, Fludarabine Phosphate, Cyclophosphamide
- 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.
RituximabDrug
Intravenous repeating dose
Intravenous repeating dose
CyclophosphamideDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | Active comparator | Not described Receives: Drug: Fludarabine Phosphate; Drug: Cyclophosphamide |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | Experimental | Not described Receives: Drug: Rituximab; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Final Analysis: Time to Progression-Free Survival Event
Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.
Measured: Median observation time was approximately 5 years
Secondary outcomes (12)
Overall Survival (OS)
Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
Measured: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Overall Survival (OS) Events
Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
Measured: Mean observation time at time of analysis was approximately 26 months
Event-free Survival (EFS)
Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Event-free Survival (EFS) Events
Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Disease-free Survival (DFS)
Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Disease-free Survival (DFS) Events
Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
Measured: Mean observation time at time of analysis was approximately 26 months
Final Analysis: Time to Overall Survival Event
Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.
Measured: Median observation time was approximately 5 years
Final Analysis: Time to Event-Free Survival Event
Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.
Measured: Median observation time was approximately 5 years
Final Analysis: Percentage of Participants With Complete Response
Complete response was defined as the disappearance of all signs of cancer in response to treatment.
Measured: Median observation time was approximately 5 years
Final Analysis: Time to Disease-Free Survival Event
Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.
Measured: Median observation time was approximately 5 years
Final Analysis: Duration of Response
Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.
Measured: Median observation time was approximately 5 years
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.
Measured: Median observation time was approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2004 (estimated)
- Study start31 Jul 2003
- Primary completion23 Jul 2008
- Study completion31 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen, Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090051
- Sponsor's protocol ID
- 102-14
- Other IDs
- BO17072
- Status last verified
- Jul 2017
- First submitted
- 23 Aug 2004
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.
PubMed 24916506Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.
PubMed 23525797
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL
- ClinicalTrials.gov ID
- NCT00090051
- Acronym / sponsor ID
- 102-14
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Biogen, Genentech, Inc.
- Study start
- 31 Jul 2003 (actual)
- Primary completion
- 23 Jul 2008 (actual)
- Study completion
- 31 May 2012 (actual)
- First posted
- 25 Aug 2004 (estimated)
- Results
- Posted 23 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | Active comparator | Drug: Fludarabine Phosphate, Drug: Cyclophosphamide |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | Experimental | Drug: Rituximab, Drug: Fludarabine Phosphate, Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Established diagnosis of B-cell CLL by NCI Working Group criteria
- ≤1 previous line of chemotherapy
- Expected survival >6 months
- Acceptable hematologic status, liver function, renal function, and pulmonary function
Key exclusion criteria (17 listed)
- Prior treatment with interferon, rituximab or other monoclonal antibody
- Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician
- Fertile men or women of childbearing potential not using adequate contraception
- Severe Grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen
- History of fludarabine-induced or clinically significant autoimmune cytopenia
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 |
|---|---|---|
| RituximabIntravenous repeating dose | Drug | Fludarabine+Cyclophosphamide+Rituximab (FCR) |
| Fludarabine PhosphateIntravenous repeating dose | Drug | Fludarabine+Cyclophosphamide (FC), Fludarabine+Cyclophosphamide+Rituximab (FCR) |
| CyclophosphamideIntravenous repeating dose | Drug | Fludarabine+Cyclophosphamide (FC), Fludarabine+Cyclophosphamide+Rituximab (FCR) |
Primary outcome
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Time frame: Mean observation time at time of analysis was approximately 26 months
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Time frame: Mean observation time at time of analysis was approximately 26 months
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Final Analysis: Time to Progression-Free Survival Event
Time frame: Median observation time was approximately 5 years
Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.
12 secondary outcomes
Overall Survival (OS)
Time frame: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Overall Survival (OS) Events
Time frame: Mean observation time at time of analysis was approximately 26 months
Event-free Survival (EFS)
Time frame: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Event-free Survival (EFS) Events
Time frame: Mean observation time at time of analysis was approximately 26 months
Disease-free Survival (DFS)
Time frame: Mean observation time at time of analysis was approximately 26 months
Number of Participants With Disease-free Survival (DFS) Events
Time frame: Mean observation time at time of analysis was approximately 26 months
Final Analysis: Time to Overall Survival Event
Time frame: Median observation time was approximately 5 years
Final Analysis: Time to Event-Free Survival Event
Time frame: Median observation time was approximately 5 years
Final Analysis: Percentage of Participants With Complete Response
Time frame: Median observation time was approximately 5 years
Final Analysis: Time to Disease-Free Survival Event
Time frame: Median observation time was approximately 5 years
Final Analysis: Duration of Response
Time frame: Median observation time was approximately 5 years
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Time frame: Median observation time was approximately 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24916506Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.
- Derived from this study: PubMed 23525797Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
106 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Fludarabine Phosphate and Cyclophosphamide in people with Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 106 sites in 17 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in France, Italy, Russia, United Kingdom, Canada and 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) (time frame: Mean observation time at time of analysis was approximately 26 months). The study lists 3 primary outcomes in all. 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 NCT00090051, which also lists 2 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 1 Aug 2017.