Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00974233
First received: September 9, 2009
Last updated: March 18, 2014
Last verified: March 2014

September 9, 2009
March 18, 2014
October 2009
December 2011   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: March 2017 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974233 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (CR+ PR) [ Time Frame: March 2012 ] [ Designated as safety issue: No ]
  • Toxicities observed with induction chemotherapy and maintenance therapy [ Time Frame: March 2012 ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: March 2017 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Drug: Bendamustine
    90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
    Other Name: Treanda
  • Drug: Rituximab
    375 mg/m2 Day 1 every 28 days for 6 cycles
    Other Name: rituxan
  • Drug: Lenalidomide
    5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
    Other Names:
    • revlimid
    • CC-5013
Experimental: Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Interventions:
  • Drug: Bendamustine
  • Drug: Rituximab
  • Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
34
March 2017
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974233
HO08405, RV-CLL/SLL-PI-397
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Celgene Corporation
Principal Investigator: Julie Chang, MD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP