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Trial record 66 of 1150 for:    "Follicular lymphoma"

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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ClinicalTrials.gov Identifier: NCT00850499
Recruitment Status : Terminated
First Posted : February 25, 2009
Results First Posted : November 1, 2012
Last Update Posted : December 12, 2012
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Results First Submitted Date  ICMJE October 3, 2012
Results First Posted Date  ICMJE November 1, 2012
Last Update Posted Date December 12, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Complete Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
Change History Complete list of historical versions of study NCT00850499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Overall Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
  • Overall Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
  • Duration of response [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
  • Time to progression [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
  • Progression-free survival [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
  • Overall survival [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • Drug: fludarabine
    fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
  • Drug: rituximab
    rituximab 375mg/m2 on Day 1 of every 35-day cycle
  • Drug: VELCADE
    1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Interventions:
    • Drug: fludarabine
    • Drug: rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 1, 2011)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2009)
110
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Greece,   Israel,   Italy,   Spain,   Switzerland
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT00850499
Other Study ID Numbers  ICMJE 26866138-LYM-2033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Millennium Pharmaceuticals, Inc.
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Study Director: Medical Monitor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Millennium Pharmaceuticals, Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP