Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
This study is currently recruiting participants.
Verified January 2013 by Duke University
Sponsor:
Duke University
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01497275
First received: December 20, 2011
Last updated: January 30, 2013
Last verified: January 2013
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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
- Rituxan
- Velcade
- Zevalin
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497275
Contacts
| Contact: Anne Beaven, MD | 919-684-8964 | Anne.Beaven@duke.edu |
| Contact: Peggy Alton, RN | 919-681-4769 | Peggy.Alton@duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Peggy Alton, RN 919-681-4769 Peggy.Alton@duke.edu | |
| Principal Investigator: Anne Beaven, MD | |
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: | January 30, 2013 |
| 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 May 19, 2013