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Non-Hodgkins LymphomaPhase 2NCT00179673

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

A Phase 2 study testing Lenalidomide in people with Non-Hodgkins Lymphoma, run by Celgene at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects 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; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkins Lymphoma
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
15 sitesin 2 countries
Study dates
Jun 2005to Apr 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign an informed consent form.
  • Age greater than or equal to 18 years at the time of signing the informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • Biopsy-proven non-Hodgkin's lymphoma
  • Indolent lymphoma the following histologies are acceptable: a. Follicular center lymphoma, grades 1, 2; b. Extranodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT) type, c. Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e. Small lymphocytic lymphoma (SLL), f. Lymphoplasmacytoid lymphoma
  • 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
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  • Participants must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Who cannot join

  • Any of the following laboratory abnormalities
  • Absolute neutrophil count (ANC) <1,500 cells/mm^3 (1.5 x 10^9/L)
  • Platelet count <100,000/mm^3 (100 x 10^9/L)
  • Serum creatinine >2.5 mg/dL (221 mmol/L)
  • Serum Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) >5.0 x upper limit of normal (ULN)
  • Serum total bilirubin >2.0 mg/dL (34 mmol/L)
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  • Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • 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, computerized tomography (CT) scan or Magnetic resonance imaging (MRI), for at least 6 months.
  • Prior history of malignancies other than non-Hodgkin's lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the participant has been free of the disease for > or equal to 1 year.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from signing the informed consent form.
  • Known positive for human immunodeficiency virus (HIV).
  • Pregnant or lactating females.
  • Prior > or equal to grade 3 allergic reaction/hypersensitivity to thalidomide.
  • Prior > or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  • Prior use of lenalidomide.
  • Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1 of study drug therapy.
  • Known active Hepatitis C.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States11 sites

  • Alta Bates Cancer Center

    Berkeley, California, 94704

  • Harvard University

    Boston, Massachusetts, 02115

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Pacific Coast Hematology/Oncology Medical Group, Onc.

    Fountain Valley, California, 92708

  • Gunderson Clinic, Ltd.

    La Crosse, Wisconsin, 54601

  • Signal Point Hematology/Oncology

    Middletown, Ohio, 45042

  • University of Nebraska

    Omaha, Nebraska, 68198-6805

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • New York Medical Center, MBCCOP

    The Bronx, New York, 10466

Other trials in United States

Canada4 sites

  • BC Community Oncology Trialist

    Burnaby, British Columbia, V5H 4K7

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • BC Community Oncology

    North Vancouver, British Columbia, V7L 2P9

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

About this study

Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Subjects 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; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase

Being tested
Lenalidomide
Keywords
NHL, CC5013, Non-Hodgkins Lymphoma, revlimid, cc-5013, celgene
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00179673
Study groupRoleWhat they receive
LenalidomideExperimentalParticipants 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.
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Response

    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.

    Measured: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

Secondary outcomes (4)

  1. Percentage of Participants With Tumor Control

    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.

    Measured: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

  2. The Duration of Response

    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.

    Measured: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

  3. Progression Free Survival (PFS)

    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.

    Measured: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months

  4. Number of Participants With Adverse Events (AEs)

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179673
Sponsor's protocol ID
CC-5013-NHL-001
Status last verified
May 2025
First submitted
10 Sep 2005
Last updated
13 May 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Non-Hodgkins Lymphoma, run by Celgene at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00179673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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