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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: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Bendamustine
Drug: Rituximab
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: March 2017 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 34
Study Start Date: October 2009
Estimated Study Completion Date: March 2017
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974233

Locations
United States, Wisconsin
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54313
St Vincent Regional Cancer Center
Green Bay, Wisconsin, United States, 54301
Mercy Health System Heme/Onc
Janesville, Wisconsin, United States, 53548
Gundersen Clinic
LaCrosse, Wisconsin, United States, 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
University of Wisconsin, Madison
Celgene Corporation
Investigators
Principal Investigator: Julie Chang, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00974233     History of Changes
Other Study ID Numbers: HO08405, RV-CLL/SLL-PI-397
Study First Received: September 9, 2009
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
CLL
SLL

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Lenalidomide
Rituximab
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014