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TerminatedNCT00850499Updated Dec 12, 2012Results posted

Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

A Phase 2 interventional study of fludarabine and rituximab in Follicular Lymphoma, sponsored by Millennium Pharmaceuticals, Inc.. Terminated at 43 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-12.

Sponsored by Millennium Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Follicular Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 173 studies on the registry; none are open to participants now.

Of its 73 completed or terminated interventional studies of FDA-regulated products, 72 (99%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    VELCADE and fludarabine (Group A)

    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

    Drug: fludarabine · Drug: VELCADE

  • Active comparator
    fludarabine and rituximab (Group B)

    fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle

    Drug: fludarabine · Drug: rituximab

Interventions

  • Drugfludarabine

    fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle

  • Drugrituximab

    rituximab 375mg/m2 on Day 1 of every 35-day cycle

  • DrugVELCADE

    1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Up to 8 cycles (1 cycle is 35 days: 280 days)

07

Results

Posted Nov 1, 2012
Limitations and caveats
Early termination leading to small numbers of subjects analyzed

Participant flow

Participant flow — Overall Study
MilestoneVelcade + FludarabineRituximab + Fludarabine
Started48
Completed16
Not completed32
Withdrew: Adverse event31
Withdrew: Lack of efficacy01

Outcome measures

PrimaryComplete 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.

Time frame:
Up to 8 cycles (1 cycle is 35 days: 280 days)
Reported as:
Number · participants
Complete Response Rate
participantsVelcade + FludarabineRituximab + Fludarabine
Complete Response Rate23
SecondaryOverall 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.

Time frame:
Up to 8 cycles (1 cycle is 35 days: 280 days)
Reported as:
Number · participants
Overall Response Rate
participantsVelcade + FludarabineRituximab + Fludarabine
Overall Response Rate36

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Velcade + Fludarabine—2/4 (50%)4/4 (100%)
Rituximab + Fludarabine—2/8 (25%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventVelcade + FludarabineRituximab + Fludarabine
Abdominal painGastrointestinal disorders1/40/8
AnaemiaBlood and lymphatic system disorders1/40/8
Small Intestinal ObstructionGastrointestinal disorders1/40/8
DypnoeaRespiratory, thoracic and mediastinal disorders0/41/8
Febrile neutropeniaBlood and lymphatic system disorders0/41/8
General physical health deteriorationGeneral disorders0/41/8
PyrexiaGeneral disorders0/41/8
Respiratory gas exchange disorderRespiratory, thoracic and mediastinal disorders0/41/8
Most frequent other events
Showing 10 of 27
Most frequent other events
EventVelcade + FludarabineRituximab + Fludarabine
NeutropeniaBlood and lymphatic system disorders1/44/8
ConstipationGastrointestinal disorders2/40/8
ThrombocytopeniaBlood and lymphatic system disorders1/43/8
AstheniaGeneral disorders1/43/8
LeukopeniaBlood and lymphatic system disorders1/42/8
LymphopeniaBlood and lymphatic system disorders0/42/8
BlepharitisEye disorders1/40/8
DiarrhoeaGastrointestinal disorders1/40/8
Gastrointestinal painGastrointestinal disorders1/40/8
NauseaGastrointestinal disorders1/41/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Velcade + FludarabineRituximab + FludarabineTotal
<=18 years000
Between 18 and 65 years369
>=65 years123
Age Continuous
Age Continuous(years)Velcade + FludarabineRituximab + FludarabineTotal
Mean61.3 ± 12.8460.0 ± 10.0660.4 ± 10.47
Sex: Female, Male
Sex: Female, Male(Participants)Velcade + FludarabineRituximab + FludarabineTotal
Female235
Male257
Region of Enrollment
Region of Enrollment(participants)Velcade + FludarabineRituximab + FludarabineTotal
France033
Greece011
Spain101
Israel101
Germany011
Switzerland101
Italy134
08

Study locations

43 sites
  • CHU d'Amiens
    Amiens, 80, 80054, France
  • Institut Bergonie
    Bordeaux, 33, 33076, France
  • CHU Hotel Dieu
    Clermont Ferrand, 63, 63000, France
  • Centre Victor Hugo
    Le Mans, 72, 72000, France
  • CHU Caremeau
    Nimes, 30, 30029, France
  • Hoptial Saint Louis
    Paris Cedex 10, 75, 75475, France
  • Hopital Cochin
    Paris, 75, Cedex 14, 75679, France
  • Klinikum Bamberg, fachbereich 3
    Bamberg, BY 96049, Germany
  • Vivantes Klinikum am Urban
    Berlin, BE, 10967, Germany
  • Charite, group Benjamin Franklin
    Berlin, BE 12203, Germany
  • Hospital Spandau
    Berlin, BE 13585, Germany
  • Universitaetsklinikum Frankfurt
    Frankfurt, HE 60590, Germany
  • Universitatsklinikum Gottingen, zentrum Innere medicin
    Gottingen, NI 37075, Germany
  • Evangelisches Krankenhaus Hamm
    Hamm, NW 50063, Germany
  • Klinikum Idar-Oberstein GmbH
    Idar-Oberstein, RP 55743, Germany
  • Universitaetsklinikum Jena
    Jena, TH 07740, Germany
  • Universitaetsklinikum Leipzig
    Leipzig, SN 04103, Germany
  • Universitaetsklinikum Mainz
    Mainz, 55131, Germany
  • Robert Bosch Krankenhaus
    Stuttgart, BW 70376, Germany
  • Mutterhaus der Borromaeerinnen
    Trier, RP 54290, Germany
  • Universitatsklinikum Ulm
    Ulm, BW 89081, Germany
  • Klinikum der Stadt Villinger-Schwenningen
    Villingen-Schwenningen, 78050, Germany
  • Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
    Athens, 11527, Greece
  • University Hospital of Heraklion- Department of Hematology
    Heraklion- Crete, 71110, Greece
  • Haemek Medical Center - Hematology Department
    Afula, 18101, Israel
  • Rambam Med.Center - Hematology Institute
    Haifa, 31096, Israel
  • Hadassah University Hospital - Hematology Department
    Jerusalem, 91120, Israel
  • Rabin Medical Center - Hematology Institute
    Petach Tikva, 49100, Israel
  • Sheba MC - Hematology Institute
    Ramat Gan, 52621, Israel
  • Policlinico di Bari
    Bari, Italy
  • Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
    Bologna, Italy
  • Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
    Genova, Italy
  • Ospedale Niguarda Ca' Granda
    Milano, Italy
  • Azienda Ospedaliera Antonio Cardarelli
    Napoli, Italy
  • Ospedale Policlinico San Matteo Irccs
    Pavia, Italy
  • A.O.Univ.Pisana-Osp. Santa Chiara
    Pisa, Italy
  • Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
    Roma, 00161, Italy
  • Azienda Ospedaliera Santa Maria di Terni
    Terni, Italy
  • Divisione di Ematologia Ospedale San Bortolo - Hematology
    Vicenza, Italy
  • Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
    Cadiz N/a, 11009, Spain
  • Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
    Murcia N/a, 30008, Spain
  • Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
    Salamanca, 37007, Spain
  • Kantonsspital St.Gallen Department of Oncology/Hematology
    St. Gallen, 9007, Switzerland
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00850499
Lead sponsor
Millennium Pharmaceuticals, Inc.
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party
Sponsor
First posted
Feb 25, 2009
Start date
Sep 2009
Primary completion
Sep 2011
Completion
Oct 2011
Results posted
Nov 1, 2012
Last update
Dec 12, 2012

Study contacts

Medical Monitor
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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