Back to resultsPhase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Primary Purpose
Follicular Lymphoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fludarabine
rituximab
VELCADE
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 18 years or older
- Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
- Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
- Documented relapse or progression following last antineoplastic treatment
- At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
Exclusion Criteria:
Subjects with histological or clinical transformation to an aggressive lymphoma
- prior treatment with VELCADE or fludarabine.
- antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- nitrosoureas within 6 weeks before randomization
- radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- major surgery within 3 weeks before randomization
- chronic use of corticosteroids, such as dexamethasone
Sites / Locations
- CHU d'Amiens
- Institut Bergonie
- CHU Hotel Dieu
- Centre Victor Hugo
- CHU Caremeau
- Hoptial Saint Louis
- Hopital Cochin
- Klinikum Bamberg, fachbereich 3
- Vivantes Klinikum am Urban
- Charite, group Benjamin Franklin
- Hospital Spandau
- Universitaetsklinikum Frankfurt
- Universitatsklinikum Gottingen, zentrum Innere medicin
- Evangelisches Krankenhaus Hamm
- Klinikum Idar-Oberstein GmbH
- Universitaetsklinikum Jena
- Universitaetsklinikum Leipzig
- Universitaetsklinikum Mainz
- Robert Bosch Krankenhaus
- Mutterhaus der Borromaeerinnen
- Universitatsklinikum Ulm
- Klinikum der Stadt Villinger-Schwenningen
- Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
- University Hospital of Heraklion- Department of Hematology
- Haemek Medical Center - Hematology Department
- Rambam Med.Center - Hematology Institute
- Hadassah University Hospital - Hematology Department
- Rabin Medical Center - Hematology Institute
- Sheba MC - Hematology Institute
- Policlinico di Bari
- Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
- Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
- Ospedale Niguarda Ca' Granda
- Azienda Ospedaliera Antonio Cardarelli
- Ospedale Policlinico San Matteo Irccs
- A.O.Univ.Pisana-Osp. Santa Chiara
- Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
- Azienda Ospedaliera Santa Maria di Terni
- Divisione di Ematologia Ospedale San Bortolo - Hematology
- Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
- Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
- Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
- Kantonsspital St.Gallen Department of Oncology/Hematology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VELCADE and fludarabine (Group A)
fludarabine and rituximab (Group B)
Arm Description
VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
Outcomes
Primary Outcome Measures
Complete Response Rate
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Secondary Outcome Measures
Overall Response Rate
The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Full Information
NCT ID
NCT00850499
First Posted
February 24, 2009
Last Updated
December 10, 2012
Sponsor
Millennium Pharmaceuticals, Inc.
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00850499
Brief Title
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Official Title
A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VELCADE and fludarabine (Group A)
Arm Type
Experimental
Arm Description
VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
Arm Title
fludarabine and rituximab (Group B)
Arm Type
Active Comparator
Arm Description
fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
Intervention Type
Drug
Intervention Name(s)
fludarabine
Intervention Description
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
rituximab 375mg/m2 on Day 1 of every 35-day cycle
Intervention Type
Drug
Intervention Name(s)
VELCADE
Intervention Description
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Primary Outcome Measure Information:
Title
Complete Response Rate
Description
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Time Frame
Up to 8 cycles (1 cycle is 35 days: 280 days)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Time Frame
Up to 8 cycles (1 cycle is 35 days: 280 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 18 years or older
Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
Documented relapse or progression following last antineoplastic treatment
At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
Exclusion Criteria:
Subjects with histological or clinical transformation to an aggressive lymphoma
prior treatment with VELCADE or fludarabine.
antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
nitrosoureas within 6 weeks before randomization
radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
major surgery within 3 weeks before randomization
chronic use of corticosteroids, such as dexamethasone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens, 80
ZIP/Postal Code
80054
Country
France
Facility Name
Institut Bergonie
City
Bordeaux, 33
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Hotel Dieu
City
Clermont Ferrand, 63
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Victor Hugo
City
Le Mans, 72
ZIP/Postal Code
72000
Country
France
Facility Name
CHU Caremeau
City
Nimes, 30
ZIP/Postal Code
30029
Country
France
Facility Name
Hoptial Saint Louis
City
Paris Cedex 10, 75
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Cochin
City
Paris, 75, Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Klinikum Bamberg, fachbereich 3
City
Bamberg
ZIP/Postal Code
BY 96049
Country
Germany
Facility Name
Vivantes Klinikum am Urban
City
Berlin, BE
ZIP/Postal Code
10967
Country
Germany
Facility Name
Charite, group Benjamin Franklin
City
Berlin
ZIP/Postal Code
BE 12203
Country
Germany
Facility Name
Hospital Spandau
City
Berlin
ZIP/Postal Code
BE 13585
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
HE 60590
Country
Germany
Facility Name
Universitatsklinikum Gottingen, zentrum Innere medicin
City
Gottingen
ZIP/Postal Code
NI 37075
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
NW 50063
Country
Germany
Facility Name
Klinikum Idar-Oberstein GmbH
City
Idar-Oberstein
ZIP/Postal Code
RP 55743
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
TH 07740
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
SN 04103
Country
Germany
Facility Name
Universitaetsklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Robert Bosch Krankenhaus
City
Stuttgart
ZIP/Postal Code
BW 70376
Country
Germany
Facility Name
Mutterhaus der Borromaeerinnen
City
Trier
ZIP/Postal Code
RP 54290
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
BW 89081
Country
Germany
Facility Name
Klinikum der Stadt Villinger-Schwenningen
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital of Heraklion- Department of Hematology
City
Heraklion- Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Haemek Medical Center - Hematology Department
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Rambam Med.Center - Hematology Institute
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital - Hematology Department
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center - Hematology Institute
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba MC - Hematology Institute
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Policlinico di Bari
City
Bari
Country
Italy
Facility Name
Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
City
Genova
Country
Italy
Facility Name
Ospedale Niguarda Ca' Granda
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Antonio Cardarelli
City
Napoli
Country
Italy
Facility Name
Ospedale Policlinico San Matteo Irccs
City
Pavia
Country
Italy
Facility Name
A.O.Univ.Pisana-Osp. Santa Chiara
City
Pisa
Country
Italy
Facility Name
Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
Country
Italy
Facility Name
Divisione di Ematologia Ospedale San Bortolo - Hematology
City
Vicenza
Country
Italy
Facility Name
Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
City
Cadiz N/a
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
City
Murcia N/a
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Kantonsspital St.Gallen Department of Oncology/Hematology
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
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