Clinical trial NCT00096044: Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: refractory chronic lymphocytic leukemia
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2004-11-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.

Detailed description: OBJECTIVES:

Primary

* Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leukemia treated with lenalidomide (CC-5013).

Secondary

* Determine the cytostatic response rate in patients who progress on CC-5013 and are then treated with CC-5013 and rituximab.
* Determine the safety of these regimens in these patients.
* Determine time to progression in patients treated with these regimens.

OUTLINE: This is an open-label, non-randomized, pilot study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.

Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry

  * Relapsed or refractory disease
* Measurable disease, defined by 1 of the following criteria:

  * Absolute lymphocyte count ≥ 5,000/mm\^3
  * Measurable lymphadenopathy or organomegaly
* Received ≥ 1 prior therapy for CLL

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 30,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)

Renal

* Creatinine ≤ 1.5 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
* No known hypersensitivity to thalidomide
* No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration
* No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins
* No serious medical condition or laboratory abnormality that would preclude study participation
* No psychiatric illness that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior lenalidomide (CC-5013)
* No concurrent thalidomide

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No concurrent radiotherapy

Surgery

* Not specified

Other

* At least 4 weeks since prior therapy for CLL
* At least 28 days since prior experimental drug or therapy
* No other concurrent anticancer therapies
* No other concurrent investigational agents

Primary outcomes:
measure: Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months
timeFrame: at 6 Months
Secondary outcomes:
measure: Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab
timeFrame: 5 years
measure: Number of Participants With Adverse Events on Single Agent CC-5013
timeFrame: 1 year
measure: Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
timeFrame: Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.
measure: Time to Progression for Single Agent CC-5013
timeFrame: 5 years
measure: Time to Progression for the Combination Therapy of CC-5013+Rituximab
timeFrame: Every month up to 6 months and every 3 months thereafter up to 5 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Kelvin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: