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Lenalidomide in Combination With Plerixafor in Patients With Previously Treated Chronic Lymphocytic Leukemia

Phase 1
18 Years
Open (Enrolling)
Leukemia, Lymphocytic, Chronic, B-Cell

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Trial Information

Lenalidomide in Combination With Plerixafor in Patients With Previously Treated Chronic Lymphocytic Leukemia

Inclusion Criteria:

- Histologically confirmed diagnosis of CLL or SLL as established by the NCI Working
Group Response Criteria (NCI 96 Criteria).

- Received one or more prior therapies for CLL.

- Patients must have symptomatic disease requiring therapy as defined by the protocol.

- >/= 4 weeks from prior cancer therapy.

- ECOG performance status of
- All study participants must be registered into the mandatory RevAssistĀ® program, and
be willing and able to comply with the requirements of RevAssistĀ®.

Exclusion Criteria:

- Prolymphocytic leukemia (PLL).

- Richter's (large cell) transformation.

- Prior allogeneic transplant within 12 months or prior allogeneic transplant > 12
months currently receiving immunosuppressants.

- Active autoimmune hemolytic anemia.

- CNS involvement.

- Chronic enteral corticosteroids > 10mg prednisone or equivalent.

- Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome

- Use of any other experimental drug or therapy within 28 days of baseline

- Major surgery 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.

- Any prior use of lenalidomide.

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

4-16 months

Safety Issue:


Principal Investigator

Mark Lanasa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

June 2016

Related Keywords:

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Chronic Lymphocytic Leukemia
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Duke University Medical CenterDurham, North Carolina  27710