CompletedPhase 2

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

United States156 participantsStarted 2008-06-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Understand and voluntarily sign an informed consent form.
✓. Age \>/= 18 at the time of signing the informed consent form.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. 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).
✓. At least one measurable lesion according to the International workshop standardized response criteria for non-Hodgkin's lymphomas (IWG) greater than 1.5cm.
✓. ECOG performance status of \</= 2 at study entry.
✓. 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.
✓. 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.

Exclusion criteria

What they're measuring

Number of Participants With Best Overall Disease Response

Timeframe: At the end of 3 courses (84 days)

Trial details

NCT IDNCT00695786

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-11

Results submitted2021-07-11

View on ClinicalTrials.gov More Ann Arbor Stage III Grade 1 Follicular Lymphoma trials