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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Fludarabine Phosphate
Cyclophosphamide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 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

Sites / Locations

  • Uab Comprehensive Cancer Center
  • Pacific Coast Hematology/Oncology Medical Group
  • California Cancer Center Woodward Park; Community Medical Centers
  • Rush-Presbyterian St. Luke'S Medical Center
  • Duke University Medical Center
  • Milton S. Hershey Medical Center; Penn State Cancer Inst.
  • Concord Repatriation General Hospital; Haematology
  • Mater Hospital; Division of Cancer Services
  • Frankston Hospital; Oncology/Haematology
  • Peter Maccallum Cancer Institute; Medical Oncology
  • ZNA Stuivenberg
  • Institut Jules Bordet
  • UZ Leuven Gasthuisberg
  • Uni of Alberta Hospital
  • BCCA-Vancouver Cancer Centre
  • Health Science Centre
  • QEII HSC; Oncology
  • Hamilton Health Sciences - Juravinski Cancer Centre; Hematology
  • The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704
  • Sunnybrook Odette Cancer Centre
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Mcgill University - Royal Victoria Hospital; Oncology
  • Righospitalet, Hæmatologisk Klinik
  • Aarhus Universitetshospital, Hæmatologisk Afdeling R
  • Hopital Avicenne; Hematologie Biologique
  • Hopital Clemenceau; Hematologie Clinique
  • Chu Estaing; Hematologie Clinique Adultes
  • Hopital Henri Mondor; Hematologie Clinique
  • Clinique Victor Hugo; Chimiotherapie
  • Hopital Claude Huriez; Hematologie
  • Hopital Edouard Herriot; Bat.E-Hematologie
  • Centre Leon Berard; Departement Oncologie Medicale
  • Institut J Paolii Calmettes; Onco Hematologie 1
  • Hôpital Lapeyronie; Hématologie Oncologie Médicale
  • Hopital Hotel Dieu Et Hme;Hopital De Jour
  • Hotel Dieu; Hematologie- Oncologie
  • Inserm Cic 9504
  • Hopital Pitie Salpetriere; Hematologie Clinique
  • Ch Lyon Sud; Hemato Secteur Jules Courmont
  • Chu La Miletrie; Hdj Cons Hemato Cancerologie
  • Centre Henri Becquerel; Hematologie
  • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
  • Hopitaux De Brabois; Hematologie Medecine Interne
  • Szent Laszlo Hospital; Hematology Dept
  • National Institute of Oncology, A Dept of Internal Medicine
  • Országos Gyógyintézeti Központ; Haematologiai Osztaly
  • Uni of Debrecen; 2Nd Clinic of Internal Medicine
  • University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
  • Uni of Pecs; Dept of Internal Medicine
  • University of Szeged, II Dept of Internal Medicine
  • A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • Ospedale S. Eugenio; Divisione Di Ematologia
  • Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • Irccs Policlinico San Matteo; Divisione Di Ematologia
  • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
  • Ospedale Di Vicenza; Nefrologia, Ematologia
  • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
  • Academisch Medisch Centrum Universiteit Amsterdam
  • Leyenburg Ziekenhuis; Haematology
  • Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Christchurch Hospital; Canterbury Health Laboratories
  • Wellington Hospital; Regional Oncology Unit
  • Haukeland Universitetshospital; Medicine Dept
  • Rikshospitalet Uni Hospital
  • Medical University School; Dept. of Haematology
  • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
  • Akademii Medycznej W; Klinika Hematologii
  • Klin. Chorob Wewnetrznych I Hemat. Z Osrodkiem Transplant. Szpiku
  • Instytut Hematologii I Transfuzjologii; Klinika Chorob Wewnetrznych I Hematologii
  • Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.
  • Fundeni Clinical Inst. ; Hematology Dept
  • Spitalul Clinic Coltea; Clinica de Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
  • Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
  • Haematology Research Center; Haematology
  • City Clinical Botkin's Hospital; City Hematological Center
  • Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
  • Regional Clinical Hospital N.A. Kalinin; Hematology Dept
  • Research Inst. Hematology /Blood Transfusion ; Hemablastosis, Supression Hemopoesis & B M Transplant
  • Regional Clinical Hospital; Hematology Dept. #2 For B M Transplantation & High Dose Chemo.
  • Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
  • S.-Peterburg Pavlov State Medical University ; Haematology
  • State Medical Inst. Municipal Hospital #31; Oncology & Hematology Dept. With the Usechemo. in Adult
  • Hospital Universitario de la Princesa; Servicio de Hematologia
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia
  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Hospital Universitario Miguel Servet; Servicio Hematologia
  • Karolinska Inst. , Huddinge Uni Hospital; Depart. of Hematology
  • Universitetssjukhuset i Linköping, Hematologkliniken
  • Royal Bournemouth General Hospital; Haematology
  • Addenbrookes Hospital; Haematology
  • Stobhill Hospital; Dept of Haematology
  • Leeds General Infirmary; Medicine
  • Leicester Royal Infirmary; Dept of Haematology
  • Royal Liverpool Uni Hospital; Haematology
  • St. Bartholomew'S Hospital; Dept of Medical Oncology
  • King'S College Hospital; Haematology
  • Royal Marsden Hospital; Academic Dept of Haematology
  • Pinderfields General Hospital; Dept of Haematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fludarabine+Cyclophosphamide (FC)

Fludarabine+Cyclophosphamide+Rituximab (FCR)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Final Analysis: Percentage of Participants With Complete Response
Complete response was defined as the disappearance of all signs of cancer in response to treatment.
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.
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.
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.

Full Information

First Posted
August 23, 2004
Last Updated
July 5, 2017
Sponsor
Hoffmann-La Roche
Collaborators
Biogen, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00090051
Brief Title
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 31, 2003 (Actual)
Primary Completion Date
July 23, 2008 (Actual)
Study Completion Date
May 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Biogen, Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fludarabine+Cyclophosphamide (FC)
Arm Type
Active Comparator
Arm Title
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Final Analysis: Time to Progression-Free Survival Event
Description
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.
Time Frame
Median observation time was approximately 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Number of Participants With Overall Survival (OS) Events
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Number of Participants With Event-free Survival (EFS) Events
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Disease-free Survival (DFS)
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Number of Participants With Disease-free Survival (DFS) Events
Description
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.
Time Frame
Mean observation time at time of analysis was approximately 26 months
Title
Final Analysis: Time to Overall Survival Event
Description
Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.
Time Frame
Median observation time was approximately 5 years
Title
Final Analysis: Time to Event-Free Survival Event
Description
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.
Time Frame
Median observation time was approximately 5 years
Title
Final Analysis: Percentage of Participants With Complete Response
Description
Complete response was defined as the disappearance of all signs of cancer in response to treatment.
Time Frame
Median observation time was approximately 5 years
Title
Final Analysis: Time to Disease-Free Survival Event
Description
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.
Time Frame
Median observation time was approximately 5 years
Title
Final Analysis: Duration of Response
Description
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.
Time Frame
Median observation time was approximately 5 years
Title
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Description
Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.
Time Frame
Median observation time was approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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
Facility Information:
Facility Name
Uab Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Pacific Coast Hematology/Oncology Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Center Woodward Park; Community Medical Centers
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Rush-Presbyterian St. Luke'S Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Milton S. Hershey Medical Center; Penn State Cancer Inst.
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Concord Repatriation General Hospital; Haematology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Mater Hospital; Division of Cancer Services
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Frankston Hospital; Oncology/Haematology
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter Maccallum Cancer Institute; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Uni of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Health Science Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
QEII HSC; Oncology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences - Juravinski Cancer Centre; Hematology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Mcgill University - Royal Victoria Hospital; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Righospitalet, Hæmatologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Hæmatologisk Afdeling R
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hopital Avicenne; Hematologie Biologique
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Clemenceau; Hematologie Clinique
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chu Estaing; Hematologie Clinique Adultes
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Henri Mondor; Hematologie Clinique
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Clinique Victor Hugo; Chimiotherapie
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Hopital Claude Huriez; Hematologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Herriot; Bat.E-Hematologie
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J Paolii Calmettes; Onco Hematologie 1
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hôpital Lapeyronie; Hématologie Oncologie Médicale
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Hotel Dieu Et Hme;Hopital De Jour
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hotel Dieu; Hematologie- Oncologie
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Inserm Cic 9504
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Pitie Salpetriere; Hematologie Clinique
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Ch Lyon Sud; Hemato Secteur Jules Courmont
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Chu La Miletrie; Hdj Cons Hemato Cancerologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Henri Becquerel; Hematologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hopitaux De Brabois; Hematologie Medecine Interne
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Szent Laszlo Hospital; Hematology Dept
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
National Institute of Oncology, A Dept of Internal Medicine
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Országos Gyógyintézeti Központ; Haematologiai Osztaly
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Uni of Debrecen; 2Nd Clinic of Internal Medicine
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Uni of Pecs; Dept of Internal Medicine
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
University of Szeged, II Dept of Internal Medicine
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale S. Eugenio; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Irccs Policlinico San Matteo; Divisione Di Ematologia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Di Vicenza; Nefrologia, Ematologia
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
Academisch Medisch Centrum Universiteit Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leyenburg Ziekenhuis; Haematology
City
Den Haag
ZIP/Postal Code
2545 CG
Country
Netherlands
Facility Name
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital; Canterbury Health Laboratories
City
Christchurch
Country
New Zealand
Facility Name
Wellington Hospital; Regional Oncology Unit
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
Haukeland Universitetshospital; Medicine Dept
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Rikshospitalet Uni Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Medical University School; Dept. of Haematology
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Akademii Medycznej W; Klinika Hematologii
City
Poznan
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Klin. Chorob Wewnetrznych I Hemat. Z Osrodkiem Transplant. Szpiku
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Instytut Hematologii I Transfuzjologii; Klinika Chorob Wewnetrznych I Hematologii
City
Warszawa
ZIP/Postal Code
00-957
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Fundeni Clinical Inst. ; Hematology Dept
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea; Clinica de Hematologie
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Haematology Research Center; Haematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
City Clinical Botkin's Hospital; City Hematological Center
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Regional Clinical Hospital N.A. Kalinin; Hematology Dept
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Research Inst. Hematology /Blood Transfusion ; Hemablastosis, Supression Hemopoesis & B M Transplant
City
St Petersburg
ZIP/Postal Code
193024
Country
Russian Federation
Facility Name
Regional Clinical Hospital; Hematology Dept. #2 For B M Transplantation & High Dose Chemo.
City
St Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
S.-Peterburg Pavlov State Medical University ; Haematology
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Medical Inst. Municipal Hospital #31; Oncology & Hematology Dept. With the Usechemo. in Adult
City
St Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Hospital Universitario de la Princesa; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Univ. 12 de Octubre; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Hematologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Karolinska Inst. , Huddinge Uni Hospital; Depart. of Hematology
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Universitetssjukhuset i Linköping, Hematologkliniken
City
Linkoeping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Royal Bournemouth General Hospital; Haematology
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrookes Hospital; Haematology
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Stobhill Hospital; Dept of Haematology
City
Glasgow
ZIP/Postal Code
G83 8NG
Country
United Kingdom
Facility Name
Leeds General Infirmary; Medicine
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Dept of Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Uni Hospital; Haematology
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
St. Bartholomew'S Hospital; Dept of Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King'S College Hospital; Haematology
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Academic Dept of Haematology
City
Sutton
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Pinderfields General Hospital; Dept of Haematology
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24916506
Citation
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.
Results Reference
derived
PubMed Identifier
23525797
Citation
Dufour 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.
Results Reference
derived

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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

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