Status:
TERMINATED
Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Mantle-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 lymph...
Detailed Description
This is a non-randomized, unblinded single arm Phase II trial to evaluate the combination of yttrium90 ibritumomab tiuxetan and bortezomib in patients with relapsed/refractory mantle cell lymphoma (MC...
Eligibility Criteria
Inclusion
- Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.
- Age \> 18 years old
- Expected survival \>/= 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at initiation of study (Appendix I).
- Laboratory tests meet the levels specified in the protocol
Exclusion
- 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 central nervous system (CNS) involvement
- Bone Marrow Involvement \>/= 25% within 30 days of initiation of study treatment
- Pregnant or breast feeding
- No patients who have received Granulocyte colony-stimulating factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01497275
Start Date
February 1 2012
End Date
May 1 2014
Last Update
July 15 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710