Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma

Part of paid clinical trials in Clive, Iowa.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01429025
Phase
PHASE1
Status
Completed

Conditions

  • Refractory/Relapsed Indolent Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    IV
  • bendamustine — DRUG
    IV
  • lenalidomide — DRUG
    PO

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells. PURPOSE: This phase I trial studies the side effects and the best dose of giving lenalidomide together with rituximab and bendamustine hydrochloride in treating patients with refractory or relapsed indolent non-Hodgkin lymphoma.

Key Dates

Start date
May 31, 2012
Status verified
Oct 2019
Primary completion
Nov 30, 2014
Completion
Jul 1, 2019

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab, bendamustine and lenalidomide
    Patients receive rituximab IV on day 1, bendamustine IV on days 1-2, and lenalidomide PO on days 1-10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum-tolerated dose of lenalidomide in combination with bendamustine hydrochloride and rituximab [ Time Frame: Up to 28 days ]

Locations (17)

FacilityCityStateZIPSite coordinators
Medical Oncology and Hematology Associates-West Des MoinesCliveIowa50325-
Mercy Cancer Center-West LakesCliveIowa50325-
Iowa Lutheran HospitalDes MoinesIowa50316-
Iowa Methodist Medical CenterDes MoinesIowa50309-
Iowa Oncology Research Association CCOPDes MoinesIowa50309-
Medical Oncology and Hematology AssociatesDes MoinesIowa50314-
Medical Oncology and Hematology Associates-Des MoinesDes MoinesIowa50309-
Mercy Medical Center - Des MoinesDes MoinesIowa50314-
Mercy Medical Center-Sioux CitySioux CityIowa51104-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
St. Luke's Regional Medical CenterSioux CityIowa51104-
Mercy Medical Center-West LakesWest Des MoinesIowa50266-
Methodist West HospitalWest Des MoinesIowa50266-7700-
Mayo ClinicRochesterMinnesota55905-
Mid Dakota ClinicBismarckNorth Dakota58501-
Saint Alexius Medical CenterBismarckNorth Dakota58501-
Sanford Bismarck Medical CenterBismarckNorth Dakota58501-

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