Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients with Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    I/II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 07-007992
    • Jacksonville, Florida: 07-007992
    • Rochester, Minnesota: 07-007992
  • NCT ID:

    NCT00670358
  • Sponsor Protocol Number:

    MC078E

About this study

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large cell or grade 3A/B follicular lymphoma
    • Newly diagnosed disease
    • Stage II, III, or IV disease
  • Measurable disease, defined as ≥ 1 lesion ≥ 1.5 cm in one diameter, as detected by CT scan or PET-CT scan (PET/CT fusion)
  • CD20-positive disease
  • No post-transplant lymphoproliferative disorder (PTLD)
  • No CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
  • Alkaline phosphatase ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
  • AST ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
  • Fertile male patients must use effective contraception during and for ≥ 28 days after completion of study therapy, even if they have had a successful vasectomy
  • No blood, sperm, or semen donation during and for ≥ 28 days after completion of study therapy
  • Willing to return to enrolling institution for follow-up
  • Willing to provide blood samples for translational research purposes
  • No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with the proper assessment of safety and toxicity of the prescribed study regimen
  • No known HIV positivity
  • Not immunocompromised
  • No concurrent uncontrolled illness including, but not limited to, any of the following:
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situation that would preclude compliance with study requirements
  • No other active malignancy, except localized nonmelanotic skin cancer or any cancer that, in the judgment of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Ejection fraction ≥ 45% by MUGA or ECHO
  • No history of life threatening or recurrent thrombosis/embolism (unless on anticoagulation therapy during study treatment)

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to ≥ 25% of the bone marrow
  • No concurrent erythroid-stimulating agents (e.g., Procrit, Aranesp)
  • No other concurrent treatment for lymphoma
  • No concurrent radiotherapy, chemotherapy, or immunotherapy for another active malignancy
  • Able to receive concurrent prophylactic anticoagulation therapy (e.g., low-dose aspirin [81 mg] daily or an alternative prophylaxis [e.g., warfarin or low molecular weight heparin])

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015