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

Celgene

Status and phase: Completed; Phase 1

Conditions: Leukemia, B-Cell, Chronic; Chronic Lymphocytic Leukemia

Treatments: Drug: lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419250

CC-5013-CLL-001

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 5 patient groups

dose-escalation to 5 mg lenalidomide (len)

Experimental group

Description:

escalate up to 5 mg once daily / 28-day cycle

Treatment:

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

dose-escalation to 10 mg lenalidomide (len)

Experimental group

Description:

escalate up to 10 mg once daily / 28-day cycle

Treatment:

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

dose-escalation to 15 mg lenalidomide (len)

Experimental group

Description:

escalate up to 15 mg once daily / 28-day cycle

Treatment:

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

dose-escalation to 20 mg lenalidomide (len)

Experimental group

Description:

escalate up to 20 mg once daily / 28-day cycle

Treatment:

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

dose-escalation to 25 mg lenalidomide (len)

Experimental group

Description:

escalate up to 25 mg once daily / 28-day cycle

Treatment:

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide

Drug: lenalidomide