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Non-Hodgkins LymphomaPhase 2NCT00179660

Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)

A Phase 2 study testing Lenalidomide in people with Non-Hodgkins Lymphoma, run by Celgene Corporation at 8 sites in United States.

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

To determine the activity of lenalidomide in relapsed or refractory aggressive NHL. 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
50 participants
Where
8 sitesUnited States
Study dates
Aug 2005to Jun 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
  • Aggressive lymphoma, the following histologies are acceptable: Follicular center lymphoma, grade 3, Diffuse large cell, Mantle cell, Transformed
  • Relapsed or refractory to previous therapy for lymphoma. Patients 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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  • Patients 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 aspartate transaminase (AST) or alanine transaminase (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 subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • All patients with central nervous system (CNS) disease with the exception of those patients 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 (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 subject 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 subject from signing the informed consent form
  • Known positive for human immunodeficiency virus (HIV)
  • Pregnant or lactating females
  • Prior > or equal to grade 3 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) allergic reaction/hypersensitivity to thalidomide
  • Prior > or equal to grade 3 NCI CTCAE 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

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Pacific Coast Hematology/Oncology Medical Group, Onc.

    Fountain Valley, California, 92708

  • Gunderson Clinic, Ltd

    La Crosse, Wisconsin, 54601

  • Sylvester Cancer CenterUniversity Of Miami

    Miami, Florida, 33136

  • University of Nebraska

    Omaha, Nebraska, 68198-6805

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC David Cancer Center

    Sacramento, California, 95817

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • New York Medical Center, MBCCOP

    The Bronx, New York, 10466

Other trials in United States

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 Aggressive Non-Hodgkin's Lymphoma

To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.

Being tested
Lenalidomide
Keywords
celgene, cc-5013, CC5013, NHL, Non-Hodgkins Lymphoma, Revlimid
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.

  • LenalidomideDrug

    Also called CC-5013, Revlimid®

    Capsules for oral administration.

Study groups in NCT00179660
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, lenalidomide treatment was discontinued for any reason, or the study was terminated.
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 3.7 months, with a maximum of 32.5 months.

Secondary outcomes (5)

  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 3.7 months, with a maximum of 32.5 months.

  2. 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 3.7 months, with a maximum of 32.5 months.

  3. Duration of Tumor Control

    The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. 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 3.7 months, with a maximum of 32.5 months.

  4. Progression-free Survival

    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 3.7 months, with a maximum of 32.5 months.

  5. 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 15.2 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 startAug 2005
  3. Primary completionJun 2008
  4. Study completionJun 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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179660
Sponsor's protocol ID
CC-5013-NHL-002
Status last verified
Dec 2015
First submitted
13 Sep 2005
Last updated
21 Jan 2016

Publications

  • Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. doi: 10.1200/JCO.2007.15.3429. Epub 2008 Jul 7.

    PubMed 18606983

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 Corporation at 8 sites in United States.

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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 2 Sep 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 3.7 months, with a maximum of 32.5 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 NCT00179660, which also lists 1 linked publication.

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 21 Jan 2016.

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