Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma

Stopped early · Phase 2

Conditions studied: Mantle-Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT01497275
Run by: Duke University
People needed: 5
Starts: 2012-02-01
Expected to finish: 2014-05-01
Last updated by the study team: 2015-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.