Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

Conditions

• Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
• Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Lenalidomide — DRUG
  Given PO
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine Sulfate — DRUG
  Given IV

Study Details

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Key Dates

Start date

Aug 27, 2013

Status verified

Apr 2026

Primary completion

Mar 26, 2020

Completion

Dec 31, 2026

Study Design

Enrollment

349 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (rituximab, combination chemotherapy, lenalidomide)
  Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm B (rituximab, combination chemotherapy)
  Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

3-year Progression-free Survival Rate [ Time Frame: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported ]

Locations (502)

Find similar trials in Anchorage, AK

Related Studies

• A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
  EARLY_PHASE1 · Recruiting · AIDS Malignancy Consortium · Miami, Florida