Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01497275
First received: December 20, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma.

Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells and releasing radiation to damage those cells. both Zevalin and Rituxan are given in this study, along with Velcade.


Condition Intervention Phase
Mantle-Cell Lymphoma
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Response rate (Complete response + Partial response) [ Time Frame: at 24 months of treatment ] [ Designated as safety issue: No ]
    Disease will be assessed every 3 months until month 24. The Cheson criteria will be used to define response.


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival will be defined as the time from on-study to death due to any cause.


Estimated Enrollment: 35
Study Start Date: February 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
    Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
    Other Names:
    • Rituxan
    • Velcade
    • Zevalin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.
  • Age > 18 years old
  • Expected survival >/= 3 months
  • ECOG performance status of 0, 1 or 2 at initiation of study (Appendix I).
  • Laboratory tests meet the levels specified in the protocol

Exclusion Criteria:

  • Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks of study initiation. However, if they have received nitrosurea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received.
  • No limitations to number of prior therapies
  • No prior radioimmunotherapy (RIT)
  • Prior bortezomib is allowed
  • Patient must be fully recovered from all toxicities associated with prior surgery, radiation treatment, chemotherapy or immunotherapy.
  • No active, serious infection or medical or psychiatric illness likely to interfere with participation in this clinic trial
  • No known HIV infection
  • No active CNS involvement
  • Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment
  • Pregnant or breast feeding
  • No patients who have received G-CSF or GM-CSF within the 14 days prior to initiating protocol
  • No patient who has had major surgery within the four weeks prior to initiating protocol therapy
  • No patients with pleural effusion or significant ascites
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497275

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Anne Beaven, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01497275     History of Changes
Other Study ID Numbers: Pro00032517
Study First Received: December 20, 2011
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antibodies, Monoclonal
Bortezomib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014