Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia - Full Text View

Sponsor:	Roswell Park Cancer Institute
Collaborator:	Celgene Corporation
Information provided by (Responsible Party):	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00096044

Purpose

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.

Condition	Intervention	Phase
Leukemia	Biological: rituximab Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Rituximab Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients achieving a CR, PR, or SD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Number, type, and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	March 2004
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

IV

Oral

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096044

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Celgene Corporation

Investigators

Principal Investigator:

Kelvin Lee, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00096044 History of Changes
Other Study ID Numbers:	CDR0000391767, RPCI-I-18103, CELGENE-RV-CLL-PI-005
Study First Received:	November 9, 2004
Last Updated:	October 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

refractory chronic lymphocytic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Rituximab
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012