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B-cell Chronic Lymphocytic LeukemiaNCT01649791

Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia

A study testing lenalidomide, laboratory biomarker analysis and lymph node biopsy in people with B-cell Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical trial studies lenalidomide as chemoprevention in treating patients with high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the use of certain drugs to keep cancer from forming. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide, laboratory biomarker analysis and lymph node biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jan 2010to Oct 2014
Phase
Interventional
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

  • Patients must have a definitive diagnosis of B-CLL as defined by the International Workshop on CLL (IWCll) criteria Patient must have early stage B-CLL defined as Rai stage 0, 1 or 2 Patients must not have received any prior treatment for management of B-CLL
  • Patients must be assessed to have high risk B-CLL as defined by either one of the following criterion:
  • High-risk cytogenetics (either 17p deletion or 11q deletion);
  • Unmutated immunoglobulin heavy chain gene rearrangement Patents must understand and voluntarily sign an informed consent form Able to adhere to the study visit schedule and other protocol requirements Patients must have measurable disease either an absolute lymphocyte counts (ALC) of more than 5,000/ul or measurable lymphadenopathy or organomegaly Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10-14 days prior to and again within 24 hours before starting lenalidomide and must either commit to continue abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure Able to take aspirin (81 or 325mg) or warfarin sodium daily as prophylactic anticoagulation Absolute neutrophil count >= 1.0 x 10^9/L Platelet count >= 30 x 10^9/L Serum creatinine =< 1.5 x upper limit of normal (ULN) Total bilirubin =< 1.5 mg/dL Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2 x ULN or =< 5 x ULN if hepatic metastases are present

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Pregnant or lactating females (lactating females must agree not to breast feed while taking lenalidomide) 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 Use of any other experimental drug or therapy within 28 days of baseline Known hypersensitivity to thalidomide or lenalidomide Prior history of development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Patients who have been treated with any prior therapy for B-CLL Patients with history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off therapy for that disease for > 3 years) Patient with history of cardiac arrest within the past 6 months Any prior use of lenalidomide Concurrent use of other anti-cancer agents or treatments Known history of hepatitis B or C Known human immunodeficiency virus (HIV) positive status

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)

This clinical trial studies lenalidomide as chemoprevention in treating patients with high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease progression in patients with early stage B-cell chronic lymphocytic leukemia

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine time to progression in patients with high risk CLL.

SECONDARY OBJECTIVES:

  1. Overall response rate including (complete remission [CR]+partial remission [PR]) of lenalidomide.

II. To determine the incidence of immune mediated flare reaction. III. To characterize the toxicity profile of single agent lenalidomide in previously untreated B-CLL.

IV. To correlate expression of B-CLL co-stimulatory ligands and clinical efficacy of lenalidomide in this patient population.

  1. To conduct correlative studies.

OUTLINE: Patients receive lenalidomide orally (PO) once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.

Being tested
lenalidomide, laboratory biomarker analysis, lymph node biopsy, bone marrow aspiration, pharmacological study
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given orally

  • laboratory biomarker analysisOther

    Correlative study

  • lymph node biopsyProcedure or surgery

    Also called Biopsy of Lymph Node

    Correlative study

  • bone marrow aspirationProcedure or surgery

    Correlative study

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative study

  • flow cytometryOther

    Correlative study

Study groups in NCT01649791
Study groupRoleWhat they receive
Treatment (lenalidomide as chemoprevention)ExperimentalPatients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lenalidomide; Other: laboratory biomarker analysis; Procedure: lymph node biopsy; Procedure: bone marrow aspiration; Other: pharmacological study; Other: flow cytometry

What is being measured

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

  1. Median Progression-free Survival

    Measured: 24 months

Secondary outcomes (3)

  1. Overall Response Rate (CR+PR)

    Measured: 24 months

  2. Incidence of Immune Mediated Flare Reaction

    Number of participants with Tumour flare.

    Measured: 24 months

  3. Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry

    PI left the institute and the data was not collected.

    Measured: 8 days

Timeline

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

  1. First posted25 Jul 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2012
  4. Study completionOct 2014

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649791
Sponsor's protocol ID
I 136908
Other IDs
NCI-2009-01327
Status last verified
May 2016
First submitted
23 Jul 2012
Last updated
30 Jun 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing lenalidomide, laboratory biomarker analysis and lymph node biopsy in people with B-cell Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Roswell Park Cancer Institute at 1 site 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2014). 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?

Median Progression-free Survival (time frame: 24 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 NCT01649791.

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 30 Jun 2016.

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