Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma
NCT ID: NCT00695786
Last Updated: 2021-10-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2008-06-10
2020-07-11
Brief Summary
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Detailed Description
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I. To evaluate the overall response rate of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma (NHL).
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma.
OUTLINE: Participants are assigned to 1 of 2 drug schedules.
SCHEDULE A: Participants receive lenalidomide orally (PO) on days 1-21 and rituximab intravenously (IV) over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
SCHEDULE B: Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 6 months.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Schedule A (lenalidomide, rituximab)
Participants receive lenalidomide PO on days 1-21 and rituximab IV over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Lenalidomide
Given PO
Rituximab
Given IV
Schedule B (lenalidomide, rituximab)
Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Lenalidomide
Given PO
Rituximab
Given IV
Interventions
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Lenalidomide
Given PO
Rituximab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>/= 18 at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Untreated indolent non-Hodgkin's lymphoma stage III-IV including small lymphocytic lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiation for localized disease allowed).
5. At least one measurable lesion according to the International workshop standardized response criteria for non-Hodgkin's lymphomas (IWG) greater than 1.5cm.
6. ECOG performance status of \</= 2 at study entry.
7. Laboratory test results within these ranges: Absolute neutrophil count \>/= 1.5 x 10\^9/L; Platelet count \>/=100 x 10\^9/L; Serum creatinine \</= 2.0 mg/dL; Total bilirubin \</=1.5 mg/dL; AST (SGOT) and ALT (SGPT) \</=2 x ULN or \</=5 x ULN if hepatic metastases are present.
8. Disease free of prior malignancies for \>/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast, or localized prostate cancer treated with curative intent.
9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 -14 days prior to and again within 24 hours of prescribing lenalidomide and 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
11. Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
12. For patients with bulky disease (tumors \>5cm) must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.
Exclusion Criteria
2. Pregnant or breast feeding females.
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Use of any chemotherapy or experimental therapy within 28 days of enrollment.
5. Known hypersensitivity to thalidomide.
6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
7. Any prior use of lenalidomide.
8. Concurrent use of other anti-cancer agents or experimental treatments.
9. Known positive for HIV or infectious hepatitis type B or C. (Hepatitis B core antibody can be positive if Hep B surface antigen is negative and no HBV DNA in blood, indicating a cleared infection.)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Felipe Samaniego, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Fowler NH, Nastoupil LJ, Hagemeister FB, Neelapu SS, Fayad LE, LeBlanc D, Samaniego F, Cheah CY. Characteristics and management of rash following lenalidomide and rituximab in patients with untreated indolent non-Hodgkin lymphoma. Haematologica. 2015 Nov;100(11):e454-7. doi: 10.3324/haematol.2015.131144. Epub 2015 Aug 6. No abstract available.
Fowler NH, Davis RE, Rawal S, Nastoupil L, Hagemeister FB, McLaughlin P, Kwak LW, Romaguera JE, Fanale MA, Fayad LE, Westin JR, Shah J, Orlowski RZ, Wang M, Turturro F, Oki Y, Claret LC, Feng L, Baladandayuthapani V, Muzzafar T, Tsai KY, Samaniego F, Neelapu SS. Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. Lancet Oncol. 2014 Nov;15(12):1311-8. doi: 10.1016/S1470-2045(14)70455-3. Epub 2014 Oct 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01853
Identifier Type: REGISTRY
Identifier Source: secondary_id
2008-0042
Identifier Type: OTHER
Identifier Source: secondary_id
2008-0042
Identifier Type: -
Identifier Source: org_study_id