Clinical trial NCT00974233: Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Official title: Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: CLL
SLL
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-09-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).

The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
* In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
* ECOG performance status of 0-2 at study entry
* Laboratory test results within these ranges: ANC \<=1500/μL, Platelet count \<= 100,000/μL. Patients with ANC \<1500/μL or plt \<100,000/μL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible.
* creatinine clearance of \>60 mL/min as determined by the Cockcroft-Gault calculation.
* Total bilirubin \<= 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
* Serum transaminases AST (SGOT) and ALT (SGPT) \<=5x ULN, Serum alkaline phosphatase ≤5 X ULN.
* Disease free of prior malignancies for ≥ 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery).
* Patients may have received prior therapy with bendamustine or lenalidomide, but must not have disease that is refractory to bendamustine or lenalidomide.
* Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.

Exclusion Criteria:

* Has received \>5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
* Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
* Prior history or current evidence of central nervous system or leptomeningeal involvement.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Known to be positive for HIV or infectious hepatitis, type B or C.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
measure: Progression-free Survival
timeFrame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Secondary outcomes:
measure: Objective Response Rate (Complete + Partial Responses)
timeFrame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
measure: Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
timeFrame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
measure: Overall Survival
timeFrame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: St Vincent Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
city: Janesville
country: United States
facility: Mercy Health System Heme/Onc
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Oconomowoc
country: United States
facility: Oconomowoc Memorial Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Riverview Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Julie Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: