Phase 2
N=53
Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00553644 ↗Enrolled (actual)
53
Serious AEs
45.3%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants With an Overall Response Defined as Complete Response and Partial Response — 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Laboratory Biomarker Analysis (Other); Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Overall Response Defined as Complete Response and Partial Response |
21 | — |
| SECONDARY Incidence of Adverse Events |
4; 29; 17; 1 | — |
| SECONDARY Time to Progression |
0.58 | — |
| SECONDARY Overall Survival |
2.17 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 = 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)
- Platelets >= 75,000/uL
- Creatinine = = 30 mL/min (patients on dialysis are not eligible)
- Total bilirubin =< 2 x ULN (unless attributable to non-Hodgkin's lymphoma and Gilbert's disease)
- Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative
Data sourced from ClinicalTrials.gov (NCT00553644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.