Follicular LymphomaPhase 2NCT00850499
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
A Phase 2 study testing fludarabine, rituximab and VELCADE in people with Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 43 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- fludarabine, rituximab and VELCADE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 43 sitesin 7 countries
- Study dates
- Sep 2009to Oct 2011
- Phase
- Phase 2
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
Germany15 sites
Klinikum Bamberg, fachbereich 3
Bamberg, BY 96049
Charite, group Benjamin Franklin
Berlin, BE 12203
Hospital Spandau
Berlin, BE 13585
Vivantes Klinikum am Urban
Berlin, BE, 10967
Universitaetsklinikum Frankfurt
Frankfurt, HE 60590
Universitatsklinikum Gottingen, zentrum Innere medicin
Göttingen, NI 37075
Evangelisches Krankenhaus Hamm
Hamm, NW 50063
Klinikum Idar-Oberstein GmbH
Idar-Oberstein, RP 55743
Universitaetsklinikum Jena
Jena, TH 07740
Universitaetsklinikum Leipzig
Leipzig, SN 04103
Universitaetsklinikum Mainz
Mainz, 55131
Robert Bosch Krankenhaus
Stuttgart, BW 70376
Mutterhaus der Borromaeerinnen
Trier, RP 54290
Universitatsklinikum Ulm
Ulm, BW 89081
Klinikum der Stadt Villinger-Schwenningen
Villingen-Schwenningen, 78050
Italy10 sites
Policlinico di Bari
Bari
Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
Bologna
Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
Genova
Ospedale Niguarda Ca' Granda
Milan
Azienda Ospedaliera Antonio Cardarelli
Naples
Ospedale Policlinico San Matteo Irccs
Pavia
A.O.Univ.Pisana-Osp. Santa Chiara
Pisa
Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
Roma, 00161
Azienda Ospedaliera Santa Maria di Terni
Terni
Divisione di Ematologia Ospedale San Bortolo - Hematology
Vicenza
France7 sites
CHU d'Amiens
Amiens, 80054
Institut Bergonie
Bordeaux, 33076
CHU Hotel Dieu
Clermont-Ferrand, 63000
Centre Victor Hugo
Le Mans, 72000
CHU Caremeau
Nîmes, 30029
Hoptial Saint Louis
Paris Cedex 10, 75, 75475
Hopital Cochin
Paris, 75, Cedex 14, 75679
Israel5 sites
Haemek Medical Center - Hematology Department
Afula, 18101
Rambam Med.Center - Hematology Institute
Haifa, 31096
Hadassah University Hospital - Hematology Department
Jerusalem, 91120
Rabin Medical Center - Hematology Institute
Petah Tikva, 49100
Sheba MC - Hematology Institute
Ramat Gan, 52621
Spain3 sites
Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
Cadiz, 11009
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
Murcia, 30008
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
Salamanca, 37007
Greece2 sites
Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
Athens, 11527
University Hospital of Heraklion- Department of Hematology
Heraklion- Crete, 71110
Switzerland1 site
Kantonsspital St.Gallen Department of Oncology/Hematology
Sankt Gallen, 9007
About this study
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
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).
- Conditions
- Follicular Lymphoma
- Being tested
- fludarabine, rituximab, VELCADE
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludarabineDrug
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
rituximabDrug
rituximab 375mg/m2 on Day 1 of every 35-day cycle
VELCADEDrug
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
| Study group | Role | What they receive |
|---|---|---|
| VELCADE and fludarabine (Group A) | Experimental | 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 Receives: Drug: fludarabine; Drug: VELCADE |
| fludarabine and rituximab (Group B) | Active comparator | fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle Receives: Drug: fludarabine; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 cycles (1 cycle is 35 days: 280 days)
Secondary outcomes (1)
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.
Measured: Up to 8 cycles (1 cycle is 35 days: 280 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionOct 2011
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.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850499
- Sponsor's protocol ID
- 26866138-LYM-2033
- Status last verified
- Dec 2012
- First submitted
- 24 Feb 2009
- Last updated
- 12 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00850499
- Acronym / sponsor ID
- 26866138-LYM-2033
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 1 Nov 2012
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, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VELCADE and fludarabine (Group A) | Experimental | Drug: fludarabine, Drug: VELCADEVELCADE 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 and rituximab (Group B) | Active comparator | Drug: fludarabine, Drug: rituximabfludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Subjects with histological or clinical transformation to an aggressive lymphoma
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 |
|---|---|---|
| fludarabinefludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle | Drug | VELCADE and fludarabine (Group A), fludarabine and rituximab (Group B) |
| rituximabrituximab 375mg/m2 on Day 1 of every 35-day cycle | Drug | fludarabine and rituximab (Group B) |
| VELCADE1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle | Drug | VELCADE and fludarabine (Group A) |
Primary outcome
Complete Response Rate
Time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
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.
1 secondary outcome
Overall Response Rate
Time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Monitor study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
43 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fludarabine, rituximab and VELCADE in people with Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 43 sites in 7 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 5 inclusion and 7 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 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany, Italy, France, Israel, Spain and 2 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?
Yes. Results are posted in the registry (first posted 1 Nov 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?
Complete Response Rate (time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2012.