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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:
ClinicalTrials.gov Identifier:
NCT00850499
First Posted: February 25, 2009
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
  Purpose
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).

Condition Intervention Phase
Follicular Lymphoma Drug: fludarabine Drug: rituximab Drug: VELCADE Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
fludarabine 40mg/m2/day orally on Days 1 to 5 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
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850499


  Show 43 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00850499     History of Changes
Other Study ID Numbers: 26866138-LYM-2033
First Submitted: February 24, 2009
First Posted: February 25, 2009
Results First Submitted: October 3, 2012
Results First Posted: November 1, 2012
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fludarabine
Fludarabine phosphate
Rituximab
Bortezomib
Vidarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents