Lenalidomide With or Without Rituximab After Standard Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also 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. It is not yet known whether lenalidomide is more effective with or without rituximab in treating diffuse large B-cell non-Hodgkin lymphoma. PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works when given with or without rituximab after standard chemotherapy in treating patients with diffuse large B-cell non-Hodgkin lymphoma.

Key facts

Study ID

NCT00765245

Run by

Vanderbilt-Ingram Cancer Center

People needed

44

Starts

2008-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-04-11

Who can join

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

You may qualify if…

• Understand and voluntarily sign an Informed Consent form
• Age > 18 years at time of signing the Informed Consent Form
• Able to adhere to the study visit schedule and other protocol requirements.
• Patients with histological confirmation of diffuse large B cell lymphoma with at least one of the following characteristics:
• High or intermediate IPI score (See Appendix 8.0 for IPI scoring criteria)
• Patients who are still PET scan positive mid therapy with R-CHOP, but, have turned negative after completion of therapy.
• Low risk International prognostic index ie., an IPI score of <3 if age >60 years or <2 if age is less than or equal to 60 with c-myc positive by Fluorescent In situ Hybridization.
• No other previous lymphoma therapy, hormonal therapy or surgery, except for standard therapy with R-CHOP with or without radiation and with or without prophylactic Methotrexate therapy. Patients must be enrolled within 4-12 weeks of completion of therapy.
• At the time of study entry following standard therapy with R-CHOP±RT, patients should be in complete remission.
• ECOG performance status of ≤ 2 at study entry
• Laboratory test results within these ranges:
• Absolute neutrophil count ≥ 1500/mm³
• Platelet count ≥100K /mm³
• Serum creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 1.5 mg/dL
• AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
• Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
• All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the Revlimid REMS® program.
• 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 and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by the Revlimid REMS® program) 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 28 days before she starts taking 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.
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation, if patients are thought to be at an elevated risk of thrombosis.

You may not qualify if…

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• 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.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type B or C.
• A diagnosis of deep vein thromboses in the preceding 3 months of study enrollment.

Where it is running

• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center at Franklin — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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