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

This study has been terminated.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00850499
First received: February 24, 2009
Last updated: December 10, 2012
Last verified: December 2012
History of Changes

February 24, 2009
December 10, 2012
September 2009
September 2011   (final data collection date for primary outcome measure)
Complete Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
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.
Complete Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00850499 on ClinicalTrials.gov Archive Site
Overall Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
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.
  • Overall Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Follicular Lymphoma
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Greece,   Israel,   Italy,   Spain,   Switzerland
 
NCT00850499
26866138-LYM-2033
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Medical Monitor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Millennium Pharmaceuticals, Inc.
December 2012

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