Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
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Purpose
This phase II clinical trial is studying how well giving lenalidomide and rituximab together works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may kill more cancer cells
| Condition | Intervention | Phase |
|---|---|---|
|
Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma |
Biological: rituximab Drug: lenalidomide |
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 Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813, IND#70116) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL) |
- Complete response rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]The true CR rate and its 95% confidence interval will be estimated for each risk group.
- Toxicity of study treatment, assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]Data will be summarized using frequency tables.
- Time to disease progression [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used.
- Time to best response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used.
| Estimated Enrollment: | 56 |
| Study Start Date: | June 2010 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
|
Biological: rituximab
Given IV
Other Names:
Drug: lenalidomide
Given orally
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the response rate (overall and complete) to treatment with lenalidomide and rituximab in patients with follicular non-Hodgkin lymphoma (NHL) who have received no prior systemic therapy.
II. To determine the time to progression after treatment with lenalidomide and rituximab in patients with previously untreated CD20+ follicular NHL.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of this regimen in patients with previously untreated CD20+ follicular NHL.
II. To establish whether the therapeutic effects of this regimen are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
III. To correlate Fcγ receptor polymorphism profiling with response to treatment with this regimen in patients with previously untreated follicular NHL.
IV. To determine the impact of lenalidomide on immune parameters in patients with previously untreated follicular NHL.
V. To determine the impact of lenalidomide on angiogenic parameters in patients with previously untreated follicular NHL.
VI. To correlate lymphoma-associated macrophages (LAM) and FOXP3, GzB, CD10, MUM1, and BCL2 expression with response to treatment with this regimen in patients with previously untreated follicular NHL.
VII. To determine whether immune gene signatures previously identified as prognostic factors in follicular lymphoma can be applied to paraffin-embedded tissues in patients treated with rituximab, to evaluate microRNA signatures associated with these gene signatures and outcome, to validate immunohistochemical markers associated with outcome in follicular lymphoma (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1), and to investigate whether markers of angiogenesis may be of value in the prognosis of follicular NHL.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
Blood, plasma, and tissue samples may be collected periodically for correlative studies.
After completion of study treatment, patients are followed up every 4 months for 2 years and then every 6 months for up to 8 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)
- WHO grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present) disease
- Stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease
- Previously untreated disease
- CD20-antigen expression as confirmed by institutional flow cytometry or IHC
- Low- or intermediate-risk disease by Follicular Lymphoma International Prognostic Index (FLIPI) (i.e., 0-2 risk factors)
Measurable disease on either physical examination or imaging studies
- Any tumor mass > 1 cm is allowed
- Non-measurable disease alone is not allowed
Lesions that are considered non-measurable include, but are not limited to, the following:
- Bone lesions (lesions if present should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by NHL should be noted)
- No known CNS involvement by lymphoma
- ECOG performance status 0-2
- ANC ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Creatinine clearance ≥ 30 mL/min (unless attributable to NHL)
- Total bilirubin ≤ 2 times upper limit of normal (unless attributable to NHL or Gilbert disease)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two effective methods of contraception for ≥ 28 days before, during, and for ≥ 3 months after completion of study treatment
- No history of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
- No uncontrolled seizures
- No autoimmune disorder requiring active immunosuppression
Patients with HIV infection are eligible, provided they meet the following criteria:
- No evidence of coinfection with hepatitis B or C
- CD4+ cell count ≥ 400/mm^3
- No evidence of resistant strains of HIV
- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL
- If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
- No history of AIDS-defining conditions
No evidence of active hepatitis B or C infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)
- HBV-seropositive patients (HBsAg +) are eligible provided they are closely monitored for evidence of active HBV infection by HBV DNA testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last dose of rituximab
- No known human anti-chimeric antibody (HACA) positivity
- Not on dialysis
- No other concurrent investigational or non-protocol therapy for lymphoma
No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy)
- Prior involved-field radiotherapy allowed
- More than 2 weeks since prior corticosteroids, except for maintenance therapy for a nonmalignant disease
- No concurrent dexamethasone and other steroids as antiemetics
Contacts and Locations
Hide Study Locations| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| Christiana Care Health System-Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| Florida Hospital | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| Saint Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Illinois CancerCare-Bloomington | |
| Bloomington%, Illinois, United States, 61701 | |
| Graham Hospital Association | |
| Canton, Illinois, United States, 61520 | |
| Illinois CancerCare-Canton | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Illinois CancerCare-Carthage | |
| Carthage, Illinois, United States, 62321 | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Cancer and Leukemia Group B | |
| Chicago, Illinois, United States, 60606 | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Eureka Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Illinois CancerCare-Eureka | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Illinois CancerCare-Havana | |
| Havana, Illinois, United States, 62644 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Illinois CancerCare-Kewanee Clinic | |
| Kewanee, Illinois, United States, 61443 | |
| Illinois CancerCare-Macomb | |
| Macomb, Illinois, United States, 61455 | |
| Mcdonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Holy Family Medical Center | |
| Monmouth, Illinois, United States, 61462 | |
| Illinois CancerCare-Monmouth | |
| Monmouth, Illinois, United States, 61462 | |
| Community Cancer Center Foundation | |
| Normal, Illinois, United States, 61761 | |
| Illinois CancerCare-Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Bromenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Ottawa Regional Hospital and Healthcare Center | |
| Ottawa, Illinois, United States, 61350 | |
| Illinois CancerCare-Ottawa Clinic | |
| Ottawa, Illinois, United States, 61350 | |
| Pekin Cancer Treatment Center | |
| Pekin, Illinois, United States, 61554 | |
| Illinois CancerCare-Pekin | |
| Pekin, Illinois, United States, 61603 | |
| Illinois CancerCare-Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61603 | |
| Illinois Oncology Research Association CCOP | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| OSF Saint Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Illinois CancerCare-Peru | |
| Peru, Illinois, United States, 61354 | |
| Illinois Valley Hospital | |
| Peru, Illinois, United States, 61354 | |
| Illinois CancerCare-Princeton | |
| Princeton, Illinois, United States, 61356 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Illinois CancerCare-Spring Valley | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Iowa | |
| Hematology Oncology Associates-Quad Cities | |
| Bettendorf, Iowa, United States, 52722 | |
| United States, Maine | |
| Harold Alfond Center for Cancer Care | |
| Augusta, Maine, United States, 04330 | |
| Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889-5600 | |
| Union Hospital of Cecil County | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Missouri | |
| Southeast Cancer Center | |
| Cape Girardeau, Missouri, United States, 63703 | |
| University of Missouri - Ellis Fischel | |
| Columbia, Missouri, United States, 65203 | |
| Capital Region Medical Center-Goldschmidt Cancer Center | |
| Jefferson City, Missouri, United States, 65109 | |
| Comprehensive Cancer Care PC | |
| Saint Louis, Missouri, United States, 63141 | |
| Center for Cancer Care and Research | |
| Saint Louis, Missouri, United States, 63141 | |
| Missouri Baptist Medical Center | |
| Saint Louis, Missouri, United States, 63131 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Saint Francis Medical Center | |
| Grand Island, Nebraska, United States, 68803 | |
| Great Plains Regional Medical Center | |
| North Platte, Nebraska, United States, 69103 | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Hampshire | |
| Exeter Hospital | |
| Exeter, New Hampshire, United States, 03833 | |
| United States, New Jersey | |
| Cooper Hospital University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Glens Falls Hospital | |
| Glens Falls, New York, United States, 12801 | |
| Monter Cancer Center | |
| Lake Success, New York, United States, 11042 | |
| North Shore-LIJ Health System CCOP | |
| Manhasset, New York, United States, 11030 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10065 | |
| State University of New York Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Randolph Hospital | |
| Asheboro, North Carolina, United States, 27203 | |
| Mission Hospitals Inc | |
| Asheville, North Carolina, United States, 28801 | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Wayne Memorial Hospital | |
| Goldsboro, North Carolina, United States, 27534 | |
| Moses Cone Health System-Regional Cancer Center | |
| Greensboro, North Carolina, United States, 27403 | |
| East Carolina University | |
| Greenville, North Carolina, United States, 27858 | |
| Annie Penn Memorial Hospital | |
| Reidsville, North Carolina, United States, 27320 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, South Carolina | |
| McLeod Regional Medical Center | |
| Florence, South Carolina, United States, 29506 | |
| United States, Vermont | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| University of Vermont | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Peter Martin | Cancer and Leukemia Group B |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01145495 History of Changes |
| Other Study ID Numbers: | NCI-2011-02047, CALGB-50803, U10CA031946, CDR0000675161 |
| Study First Received: | June 15, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Rituximab Thalidomide Lenalidomide Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013