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Chronic Lymphocytic LeukemiaPhase 2NCT01271283

Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

A Phase 2 study testing Diagnostic Laboratory Biomarker Analysis and Lenalidomide in people with Chronic Lymphocytic Leukemia and Stage III Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Diagnostic Laboratory Biomarker Analysis and Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2010to Aug 2011
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
  • Must have high-risk B-CLL as defined by ≥ one of the following:
  • High-risk cytogenetics (either 17p deletion and/or 11q deletion)
  • Unmutated immunoglobulin heavy chain gene rearrangement
  • Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
  • No prior treatment for the management of B-CLL
Show all 35Show fewer
  • Patients must have B-CLL requiring therapy as defined by the IWCLL criteria
  • Must have measurable disease meeting one of the following criteria:
  • Absolute lymphocyte count > 5,000/μL
  • Measurable lymphadenopathy or organomegaly
  • No tumor lysis syndrome (TLS) by Cairo-Bishop definition
  • Patients with correction of electrolyte abnormalities allowed
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)
  • Uric acid normal
  • Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
  • Able to adhere to the study visit schedule and other protocol requirements
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
  • No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • No known hypersensitivity to thalidomide or lenalidomide
  • No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
  • No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years
  • No cardiac arrest within the past 6 months
  • No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
  • No other concurrent anti-cancer agents or treatments
  • More than 28 days since any prior experimental drug or therapy
  • Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
  • No prior lenalidomide

Who cannot join

None listed.

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: Lenalidomide for the Treatment of CLL Patients With High-Risk Disease

This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the time to progression in patients with high-risk chronic lymphocytic leukemia (CLL) treated with lenalidomide.

SECONDARY OBJECTIVES:

  1. To determine the clinical response (complete and partial response) in treatment-naïve patients with high-risk CLL treated with single-agent lenalidomide.

II. To determine the incidence of immune-mediated flare reaction. III. To determine the toxicity profile of single-agent lenalidomide in previously untreated patients with high-risk CLL.

IV. To conduct correlative studies in bone marrow, peripheral blood, and/or lymph nodes of patients treated with lenalidomide.

OUTLINE:

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.

After completion of study therapy, patients are followed up every 3 months for a maximum of 5 years.

Being tested
Diagnostic Laboratory Biomarker Analysis, Lenalidomide
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.

  • Diagnostic Laboratory Biomarker AnalysisOther

    Correlative studies

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given orally

Study groups in NCT01271283
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.
Receives: Other: Diagnostic Laboratory Biomarker Analysis; Drug: Lenalidomide

What is being measured

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

  1. Time to progression

    Measured: From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months

Secondary outcomes (1)

  1. Maximal clinical response (complete and partial response)

    Summarized by a sample proportion along with the exact 95% confidence interval. The time-to-progression will be graphically analyzed using standard Kaplan-Meier estimation.

    Measured: Up to 24 months

Timeline

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

  1. First posted6 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01271283
Sponsor's protocol ID
NCI-2011-02568
Other IDs
NCI-2011-02568, CDR0000692070, RPCI # I 174910, 8254, P30CA016056
Status last verified
Nov 2011
First submitted
5 Jan 2011
Last updated
4 Jun 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diagnostic Laboratory Biomarker Analysis and Lenalidomide in people with Chronic Lymphocytic Leukemia and Stage III Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) 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 35 inclusion and 0 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: withdrawn, as of the sponsor's last update on 4 Jun 2015. 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.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Time to progression (time frame: From the start of lenalidomide therapy to time of disease progression, assessed up to 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 NCT01271283.

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 4 Jun 2015.

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