Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma

Last updated: September 28, 2021
Sponsor: M.D. Anderson Cancer Center
Overall Status: Completed

Phase

2

Condition

Marginal Zone Lymphoma

Lymphoma, B-cell

Lymphoma

Treatment

N/A

Clinical Study ID

NCT00695786
2008-0042
NCI-2018-01853
2008-0042
  • Ages > 18
  • All Genders

Study Summary

This phase II trial studies how well lenalidomide works in combination with rituximab in treating participants with stage III-IV non-Hodgkin lymphoma that is growing slowly. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth, which may prevent the growth of cancer cells. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and rituximab may work better in participants with indolent non-Hodgkin lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  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 lymphocyticlymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiationfor localized disease allowed).
  5. At least one measurable lesion according to the International workshop standardizedresponse 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; Totalbilirubin </=1.5 mg/dL; AST (SGOT) and ALT (SGPT) </=2 x ULN or </=5 x ULN if hepaticmetastases are present.
  8. Disease free of prior malignancies for >/= 5 years with exception of currently treatedbasal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervixor breast, or localized prostate cancer treated with curative intent.
  9. All study participants must be registered into the mandatory RevAssist® program, andbe willing and able to comply with the requirements of RevAssist®.
  10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancytest with a sensitivity of at least 50 mIU/mL within 10 -14 days prior to and againwithin 24 hours of prescribing lenalidomide and must either commit to continuedabstinence from heterosexual intercourse or begin TWO acceptable methods of birthcontrol, one highly effective method and one additional effective method AT THE SAMETIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree toongoing pregnancy testing.
  11. Men must agree to use a latex condom during sexual contact with a female of childbearing 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 usewarfarin or low molecular weight heparin.

Exclusion

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females.
  3. Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe 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 whiletaking 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 antibodycan be positive if Hep B surface antigen is negative and no HBV DNA in blood,indicating a cleared infection.)

Study Design

Total Participants: 156
Study Start date:
June 10, 2008
Estimated Completion Date:
July 11, 2020

Study Description

PRIMARY OBJECTIVES:

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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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