A Pilot/Feasibility Phase I Study of Bendamustine, Rituximab and Lenalidomide in Patients With Refractory/Relapsed Indolent NHL
- To establish the maximum-tolerated dose of lenalidomide in combination with
bendamustine hydrochloride (B) and rituximab (R) chemotherapy.
- To evaluate the toxicity profile of lenalidomide in combination with BR chemotherapy.
- To assess progression-free survival.
- To assess the overall and complete response rates of lenalidomide in combination with
BR in patients with relapsed/refractory indolent non-Hodgkin lymphoma (NHL).
- To explore changes of immune microenvironment - cytokine profile with therapy and
relation to the outcome.
- To explore biological factors associated with therapy and therapy outcome (the tumor
tissue and blood specimens will be banked for future exploratory studies).
- To assess impact of statin use on response to therapy and patient outcome.
- To store serum for vitamin D assessment and correlate the levels with outcome.
- To record any transformation to aggressive NHL events and perform exploratory studies
of association of tumor-immune microenvironment, histology, and expression of DNA
damaging and repair enzymes with transformation.
OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.
Patients receive rituximab IV over 5-8 hours on day 1, bendamustine hydrochloride IV over
30-60 minutes on days 1-2, and lenalidomide orally (PO) on days 1-10. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
Patients may undergo blood sample collection at baseline and periodically during treatment
for correlative studies. Tumor tissue samples may also be collected.
After completion of study treatment, patients are followed up for up to 5 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose of lenalidomide in combination with bendamustine hydrochloride and rituximab
Up to 28 days
Grzegorz S. Nowakowski, MD
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|Medical Oncology and Hematology Associates||Des Moines, Iowa 50309|
|Mid Dakota Clinic||Bismarck, North Dakota 58501|
|Medical Oncology and Hematology Associates-West Des Moines||Clive, Iowa 50325|
|Iowa Oncology Research Association CCOP||Des Moines, Iowa 50309|
|Mercy Medical Center - Des Moines||Des Moines, Iowa 50314|
|Medical Oncology and Hematology Associates-Des Moines||Des Moines, Iowa 50309|
|Mercy Medical Center-Sioux City||Sioux City, Iowa 51104|
|Saint Alexius Medical Center||Bismarck, North Dakota 58501|
|Methodist West Hospital||West Des Moines, Iowa 50266-7700|
|Sanford Bismarck Medical Center||Bismarck, North Dakota 58501|
|Mercy Cancer Center-West Lakes||Clive, Iowa 50325|
|Mercy Medical Center-West Lakes||West Des Moines, Iowa 50266|