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Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00179673
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 14, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Prologue Research International
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Tracking Information
First Submitted Date  ICMJE September 10, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE August 9, 2013
Results First Posted Date  ICMJE October 14, 2013
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
Percentage of Participants With Response [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]
Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following:
  • A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)
  • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To determine the activity of lenalidiomide in relapsed or refractory indolent non-Hodgkin’s lymphoma. Activity will be assessed by measuring the response rate, tumor control rate, duration of response and progression free survival.
Change History Complete list of historical versions of study NCT00179673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
  • Percentage of Participants With Tumor Control [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]
    Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. SD was defined as a response less than a PR (see above) but not Progressive Disease (PD). PD was defined as
    • ≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.
    • Appearance of any new lesion during or at the end of therapy.
  • The Duration of Response [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]
    The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.
  • Progression Free Survival (PFS) [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]
    Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months. ]
    The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:
    • Grade 1 = Mild
    • Grade 2 = Moderate
    • Grade 3 = Severe
    • Grade 4 = Life threatening
    • Grade 5 = Death
    A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory indolent NHL.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Brief Summary Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue for up to 52 weeks or until disease progression; participants who achieve a complete response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Participants will be followed for progression free survival following discontinuation from the treatment phase
Detailed Description Participants who qualified for enrollment into the study entered the treatment phase and received single-agent lenalidomide 25 mg once daily on Days 1 to 21 of every 28-day cycle. The treatment phase began on Day 1 of Cycle 1. Study visits were scheduled to occur every 28 days to coincide with the beginning of a new cycle. The start date of a new cycle was delayed if adverse events (AEs) occurred, in which case the visit date for the start of the following cycle was scheduled 28 days after the actual start date of the delayed cycle. Efficacy and safety assessments, including complete blood counts (CBCs) were performed at least every 2 weeks during Cycles 1 to 4 of the treatment phase. Participants continued in the treatment phase of the study for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkins Lymphoma
Intervention  ICMJE Drug: Lenalidomide
Lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed
Other Name: CC-5013; Revlimid®
Study Arms  ICMJE Experimental: Lenalidomide
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
Intervention: Drug: Lenalidomide
Publications * Witzig TE, Wiernik PH, Moore T, Reeder C, Cole C, Justice G, Kaplan H, Voralia M, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Vose JM. Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's Lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5404-9. doi: 10.1200/JCO.2008.21.1169. Epub 2009 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
43
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age greater than or equal to 18 years at the time of signing the informed consent form
  3. Able to adhere to the study visit schedule and other protocol requirements
  4. Biopsy-proven non-Hodgkin's lymphoma (NHL)
  5. Indolent lymphoma the following histologies are acceptable:

    1. Follicular center lymphoma, grades 1, 2,
    2. Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type,
    3. Nodal marginal zone B-cell lymphoma
    4. Splenic marginal zone B-cell lymphoma,
    5. Small lymphocytic lymphoma,
    6. Lymphoplasmacytoid lymphoma
  6. Relapsed or refractory to previous therapy for lymphoma. Participants must have received at least one prior treatment regimen such as radiation, immunotherapy, chemotherapy, OR radioimmunotherapy, and be ineligible or unwilling to undergo an autologous stem cell transplant. There is no limit on the number of prior therapies
  7. Participants must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
  9. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception or to practice complete abstinence from heterosexual intercourse during the following periods 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.

Exclusion Criteria:

  1. Any of the following laboratory abnormalities

    1. Absolute neutrophil count (ANC) <1,500 cells/mm^3 (1.5 x 10^9/L)
    2. Platelet count <100,000/mm^3 (100 x 10^9/L)
    3. Serum creatinine >2.5 mg/dL (221 mmol/L)
    4. Serum glutamic-oxaloacetic transaminase/ aspartate aminotransferase (SGOT/AST) or serum glutamic:pyruvic transaminase/alanine aminotransferase (SGPT/ALT) >5.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  3. All participants with Central Nervous System (CNS) disease with the exception of those subjects whose CNS disease has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture, Computed Tomography or Magnetic resonance imaging (CT scan or MRI), for at least 6 months.
  4. Prior history of malignancies other than NHL (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or equal to 1 year.
  5. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  6. Known positive for Human Immunodeficiency Virus (HIV).
  7. Pregnant or lactating females.
  8. Prior ≥ grade 3 (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE]) allergic reaction/hypersensitivity to thalidomide.
  9. Prior ≥ grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  10. Prior use of lenalidomide.
  11. Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1 of study drug therapy.
  12. Known active Hepatitis C.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00179673
Other Study ID Numbers  ICMJE CC-5013-NHL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene ( Celgene Corporation )
Study Sponsor  ICMJE Celgene Corporation
Collaborators  ICMJE Prologue Research International
Investigators  ICMJE
Study Director: Robert Knight, MD Celgene
PRS Account Celgene
Verification Date November 2013

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