A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Leukemia, B-Cell, Chronic
• Interventions: Drug: lenalidomide

• Registration Number: NCT00419250
• Lead Sponsor: Celgene

Brief Summary

The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-08
• Primary Completion: 2010-02-01
• Study Completion: 2010-06-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
• ECOG < or = 2
• Willing to agree to follow the pregnancy precautions.

Exclusion Criteria

• Pregnant or nursing women
• Systemic treatment for B-cell CLL within 28 days of study start
• Central nervous system involvement
• History of renal failure requiring dialysis
• Prior treatment with lenalidomide
• Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
• ANC < 1000 / ul
• Platelet count < 50,000 / ul
• Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
• AST or ALT > 3.0 x upper limit of normal
• Serum total bilirubin > 2.0 mg/dl
• Neuropathy > or = Grade 2
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• Richter's transformation (active)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose-escalation to 5 mg lenalidomide (len)	lenalidomide	escalate up to 5 mg once daily / 28-day cycle
dose-escalation to 20 mg lenalidomide (len)	lenalidomide	escalate up to 20 mg once daily / 28-day cycle
dose-escalation to 10 mg lenalidomide (len)	lenalidomide	escalate up to 10 mg once daily / 28-day cycle
dose-escalation to 15 mg lenalidomide (len)	lenalidomide	escalate up to 15 mg once daily / 28-day cycle
dose-escalation to 25 mg lenalidomide (len)	lenalidomide	escalate up to 25 mg once daily / 28-day cycle

Primary Outcome Measures

Name	Time	Method
Safety	February 2010

Secondary Outcome Measures

Name	Time	Method
Absolute lymphocyte count	February 2010
Overall survival	February 2010
Response	February 2010
Duration of response	February 2010
Time to response	February 2010
Progression free survival	February 2010
Evaluation of minimal residual disease (MRD) by flow cytometry	February 2010

Trial Locations

Locations (35)

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Alta Bates Summit Comprehensive Cancer Center; 🇺🇸 Berkeley, California, United States

Desert Hematology Oncology Medical Group, Inc.; 🇺🇸 Rancho Mirage, California, United States

Baptist Cancer Institute; 🇺🇸 Jacksonville, Florida, United States

Cancer & Blood Disease Center; 🇺🇸 Lecanto, Florida, United States

Northwest Georgia Oncology Centers, PC., Wellstar Health System; 🇺🇸 Marietta, Georgia, United States

Mountain States Tumor Institute; 🇺🇸 Boise, Idaho, United States

Robert H. Lurie Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Indiana University Medical center; 🇺🇸 Indianapolis, Indiana, United States

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