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

This study has been completed.
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00096044
First received: November 9, 2004
Last updated: June 9, 2017
Last verified: June 2017
November 9, 2004
June 9, 2017
March 2004
June 2015   (Final data collection date for primary outcome measure)
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months [ Time Frame: at 6 Months ]
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Not Provided
Complete list of historical versions of study NCT00096044 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab [ Time Frame: 5 years ]
    Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
  • Number of Participants With Adverse Events on Single Agent CC-5013 [ Time Frame: 1 year ]

    Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0

    Please refer to the adverse event reporting for more detail.

  • Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab [ Time Frame: Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab. ]
    Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0
  • Time to Progression for Single Agent CC-5013 [ Time Frame: 5 years ]
    Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
  • Time to Progression for the Combination Therapy of CC-5013+Rituximab [ Time Frame: Every month up to 6 months and every 3 months thereafter up to 5 years ]
    Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
Not Provided
Not Provided
Not Provided
 
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia
  • Biological: rituximab
    IV
  • Drug: lenalidomide
    Oral
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
Interventions:
  • Biological: rituximab
  • Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00096044
CDR0000391767
RPCI-I-18103 ( Other Identifier: Roswell Park Cancer Institute )
CELGENE-RV-CLL-PI-005 ( Other Grant/Funding Number: Celgene )
Yes
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Celgene
Principal Investigator: Kelvin Lee, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP