Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00096044
First received: November 9, 2004
Last updated: October 15, 2014
Last verified: October 2014
  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 2

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:


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: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Lenalidomide
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
Biological: rituximab
IV
Drug: lenalidomide
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 15, 2014
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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Rituximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014