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Relapsed or Refractory Chronic Lymphocytic LeukemiaPhase 2NCT00963105

Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase 2 study testing lenalidomide in people with Relapsed or Refractory Chronic Lymphocytic Leukemia, run by Celgene at 52 sites in 8 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

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
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
104 participants
Where
52 sitesin 8 countries
Study dates
19 Oct 2009to 5 Sep 2017
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

  • Age ≥ 18 years at the time of signing the informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must have a documented diagnosis of B-cell CLL
  • Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Active infections requiring systemic antibiotics
  • Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
  • Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
  • Prior therapy with lenalidomide
  • History of grade 4 rash due to prior thalidomide treatment
Show all 14Show fewer
  • Planned autologous or allogeneic bone marrow transplantation
  • Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within 12 months
  • ≥ Grade 2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
  • Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy

Trial locations and contacts

52 sites in 8 countries.

52 sites in 8 countries

United States16 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Northwestern University Medical Center Division of Hematology Oncology

    Chicago, Illinois, 60611-2927

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5149

  • UCSD Moores Cancer Center

    La Jolla, California, 92093-0820

  • Cancer and Blood Disease Center

    Lecanto, Florida, 34461

  • Long Island Jewish Medical Center CLL Research and Treatment Program

    New Hyde Park, New York, 11042

  • Drexel University, College of Medicine, Clinical Research Group

    Philadelphia, Pennsylvania, 19102

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Stanford University School of Medicine

    Stanford, California, 94305-5821

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27104

Other trials in United States

France14 sites

  • CHU Sud

    Amiens, 80054

  • Hopital Avicenne

    Bobigny, 93009

  • CHU Grenoble

    Grenoble, 38043

  • Clinique Victor Hugo

    Le Mans, 72000

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34295

  • Hopital Emile Muller

    Mulhouse, 68000

  • Hopital Pitie Salpetriere

    Paris, 75651

  • CH Perpignan - Hopital Saint-Jean

    Perpignan, 66046

  • CHRU - Hopital du Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Hopital Robert Debre

    Reims, 51092

  • CHU Rennes Hematology

    Rennes, 35033

  • CHRU Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany6 sites

  • Charite -Universitätsmedizin Berlin

    Berlin, 13353

  • Klinikum der Universitat zu Koln

    Cologne, 50924

  • Universitatsklinikum Essen

    Essen, 45122

  • Ernst-Moritz-Arndt-Universität Greifswald

    Greifswald, 17487

  • Universitatsklinikum Schleswig Holstein

    Kiel, 24116

  • University of Ulm Abteilung Innere Medizin III

    Ulm, 89081

Other trials in Germany

Italy6 sites

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce

    Lecce, 73100

  • I.R.C.C.S. Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia - IEO

    Milan, 20141

  • Universita degli Studi di Padova

    Padova, 35128

  • Universita' Degli Studi Di Perugia

    Perugia, 06100

Other trials in Italy

United Kingdom5 sites

  • St James's Institute of Oncology

    Leeds, LS9 7TF

  • St.Bartholomew's Hospital

    London, EC1M 6BQ

  • King's College Hospital

    London, SE5 9RS

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

Other trials in Canada

Spain2 sites

  • Hospital Clinic Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

Other trials in Spain

Sweden1 site

  • Karolinska Universitetssjukhuset

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Being tested
lenalidomide
Medical subject headings
Recurrence, 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

    Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

    • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
    • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
    • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Study groups in NCT00963105
Study groupRoleWhat they receive
Lenalidomide 5 mgExperimentalParticipants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Receives: Drug: lenalidomide
Lenalidomide 10 mgExperimentalParticipants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Receives: Drug: lenalidomide
Lenalidomide 15 mgExperimentalParticipants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
Receives: Drug: lenalidomide

What is being measured

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

  1. Number of Participants With Treatment-emergent Adverse Events

    Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.

    Measured: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.

    Measured: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

  2. Kaplan-Meier Estimate of Duration of Response

    Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.

    Measured: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

  3. Time to Response

    Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.

    Measured: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

  4. Kaplan-Meier Estimate of Time to Progression

    Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.

    Measured: From randomization until the end of the study; maximum time on study was 91 months.

  5. Kaplan-Meier Estimate of Event-Free Survival

    Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

    Measured: From randomization until the end of the study; maximum time on study was 91 months.

  6. Kaplan-Meier Estimate of Progression Free Survival

    Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

    Measured: From randomization until the end of the study; maximum time on study was 91 months.

  7. Kaplan-Meier Estimate of Overall Survival

    Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.

    Measured: From randomization until the end of the study; maximum time on study was 91 months.

Timeline

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

  1. First posted21 Aug 2009 (estimated)
  2. Study start19 Oct 2009
  3. Primary completion5 Sep 2017
  4. Study completion5 Sep 2017

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00963105
Sponsor's protocol ID
CC-5013-CLL-009
Other IDs
2009-009836-54, 2009
Status last verified
Oct 2018
First submitted
20 Aug 2009
Last updated
31 Oct 2018
Data monitoring committee
Yes

Publications

  • Wendtner CM, Hallek M, Fraser GA, Michallet AS, Hillmen P, Durig J, Kalaycio M, Gribben JG, Stilgenbauer S, Buhler A, Kipps TJ, Purse B, Zhang J, De Bedout S, Mei J, Chanan-Khan A. Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leuk Lymphoma. 2016;57(6):1291-9. doi: 10.3109/10428194.2015.1128540. Epub 2016 Jan 14.

    PubMed 26763349

  • Buhler A, Wendtner CM, Kipps TJ, Rassenti L, Fraser GA, Michallet AS, Hillmen P, Durig J, Gregory SA, Kalaycio M, Aurran-Schleinitz T, Trentin L, Gribben JG, Chanan-Khan A, Purse B, Zhang J, De Bedout S, Mei J, Hallek M, Stilgenbauer S. Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial. Blood Cancer J. 2016 Mar 11;6(3):e404. doi: 10.1038/bcj.2016.9.

    PubMed 26967821

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lenalidomide in people with Relapsed or Refractory Chronic Lymphocytic Leukemia, run by Celgene at 52 sites in 8 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 5 inclusion and 14 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, France, Germany, Italy, United Kingdom and 3 more countries. 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 Oct 2018). 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?

Number of Participants With Treatment-emergent Adverse Events (time frame: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.). 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 NCT00963105, which also lists 2 linked publications.

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 31 Oct 2018.

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