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Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

March 2017

Safety Issue:

No

Principal Investigator

Julie Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

HO08405

NCT ID:

NCT00974233

Start Date:

October 2009

Completion Date:

March 2017

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • CLL
  • SLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Riverview HospitalWisconsin Rapids, Wisconsin  54494
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669
St Vincent Regional Cancer CenterGreen Bay, Wisconsin  54301
Mercy Health System Heme/OncJanesville, Wisconsin  53548
Gundersen ClinicLaCrosse, Wisconsin  54601