Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Completed · Phase 2

Conditions studied: Recurrent Mantle Cell Lymphoma

In brief

This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.

Key facts

Study ID

NCT00553644

Run by

National Cancer Institute (NCI)

People needed

53

Starts

2007-11-15

Expected to finish

2014-01-21

Last updated by the study team

2018-10-30

Who can join

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

You may qualify if…

• Histologically documented mantle cell lymphoma, with the following immunophenotypic characteristics: cluster of differentiation (CD)5+, CD23-, cyclin D1+; this may be from an initial diagnostic biopsy, or one obtained at time of relapse
• Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable
• Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
• Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen expression, lack of CD23 antigen expression, and expression of cyclin D1
• Prior therapy with at least one regimen, which may have been single agent or multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents; patient may not have received prior bortezomib or lenalidomide therapy; patient must have progressive disease or refractory disease following that initial regimen(s); refractory disease will be defined as stable disease (SD) or progressive disease (PD) as best response to prior therapy, or CR or PR as initial response followed by disease progression within 6 months
• Prior autologous, but not allogeneic, stem cell transplant is allowed
• No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
• No prior radioimmunotherapy within 12 months of study entry
• No >= grade 3 peripheral neuropathy within a month prior to study entry
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm by physical exam, computed tomography (CT), magnetic resonance imaging (MRI), or conventional radiograph is acceptable; lesions that are considered non-measurable include the following:
• Bone lesions (lesions, if present, should be noted)
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis or pulmonis
• Bone marrow (involvement by non-Hodgkin lymphoma should be noted)
• No known central nervous system (CNS) involvement by lymphoma
• Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following: CD4+ cell count > 350/mm\^3; treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm\^3; no history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV-related illnesses; no concurrent zidovudine or stavudine
• Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; documentation of counseling is required on Cancer and Leukemia Group B (CALGB) form S-041
• Patients with a recent history (within 3 months of study entry) of deep vein thrombosis (DVT)/pulmonary embolism (PE) are not eligible; patients with a distant history (greater than 3 months before study entry) of DVT/PE are eligible, but must receive either prophylactic aspirin or low molecular weight heparin, unless contraindicated
• Left ventricular ejection fraction (LVEF) >= 45% by multigated acquisition (MUGA) scan or echocardiogram
• No New York Heart Association class III or class IV congestive heart failure at study entry
• No myocardial infarction within the past 6 months of study entry
• No known positivity for hepatitis A, B, or C
• Absolute neutrophil count (ANC) >= 1,000/uL (>= 500/uL if marrow involvement)

Where it is running

• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente-Cadillac — Los Angeles, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• Kaiser Permanente-Riverside — Riverside, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• Kaiser Permanente-San Diego Zion — San Diego, California, United States
• Kaiser Permanente-San Marcos — San Marcos, California, United States
• Kaiser Permanente-Woodland Hills — Woodland Hills, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Graham Hospital Association — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Heartland Cancer Research NCORP — Decatur, Illinois, United States
• Eureka Hospital — Eureka, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
• Kaiser Permanente-Anaheim — Anaheim, California, 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.