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Chronic Lymphocytic LeukemiaPhase 1/2NCT01403246

Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

A Phase 1/2 study testing Lenalidomide; Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 10 sites in Italy.

Terminated

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

Official record
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Trial summary

This is a phase I multicenter, open label study in previously untreated and elderly patients (> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Lenalidomide; Chlorambucil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
10 sitesItaly
Study dates
Nov 2011to Jan 2015
Phase
Phase 1/2
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CLL diagnosis according to the 2008 revised NCI criteria.
  • Age > 65 years or between 60 and 65 years if not suitable for fludarabine-based regimens according to the investigator's judgment.
  • ECOG performance status of ≤2 at study entry.
  • No previous treatment.
  • Advanced stage or progressive CLL according to the 2008 revised NCI criteria.
  • Disease-free of prior malignancies other than CLL for ≥3 years, with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
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  • Able to take low molecular weight heparin or in alternative, low-fixed-dose warfarin or, in alternative, low-dose aspirin.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Female subjects of childbearing potential(FCBP) must:
  • Understands the potential teratogenic risk to the unborn child and the need for effective contraception;
  • Be capable of complying with effective contraceptive measures.
  • Be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.
  • Understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test.
  • Uderstand the need and accepts to undergo pregnancy testing based on the frequency outlined in this protocol.
  • Contraception.
  • Females of childbearing potential (FCBP) enrolled in this protocol must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation.
  • The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:
  • Highly effective methods:
  • Intrauterine device (IUD)
  • Hormonal (birth control pills, injections, implants)
  • Tubal ligation
  • Partner's vasectomy
  • Additional effective methods:
  • Male condom
  • Diaphragm
  • Cervical Cap
  • Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone.
  • Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia.
  • Pregnancy testing.
  • FCBP must have two negative pregnancy tests prior to starting study drug. The first pregnancy test must be performed within 10 to 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug.
  • FCBP must agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
  • Females must agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation.
  • Male patients must:
  • Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a female of childbearing potential.
  • Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
  • If pregnancy or a positive pregnancy test does occur in the partner of a male study patient during study participation, the investigator must be notified immediately.
  • Female and male patients:
  • should be instructed never to give this medicinal product to another person and to return any unused capsules to the study doctor at the end of treatment.
  • Should not donate blood during therapy and for at least 28 days following discontinuation of study drug.
  • Male patients should not donate blood, semen or sperm during therapy or for at least 28 days following discontinuation of study drug.
  • Laboratory test results within these ranges:
  • Serum creatinine ≤1.5 mg/dL and creatinine clearance ≥ 60mL/min
  • Total bilirubin ≤1.5 mg/dL
  • AST (SGOT) and ALT (SGPT) ≤1.5 x ULN.
  • All patients must be able to understand and voluntarily sign the informed consent form.

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • A CIRS score > 6.
  • Pregnant or Lactating Females.
  • Known positive serology for HIV or active hepatitis B or C.
  • Active infection requiring systemic anti-viral, antibiotic or anti-fungal therapy.
  • History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
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  • History of renal failure requiring dialysis.
  • Known presence of alcohol and/or drug abuse.
  • History of thrombosis, thromboembolism within one year.
  • Hearth failure, arrhythmia.
  • ≥ grade 2 neuropathy.
  • Uncontrolled hyperthyroidism or hypothyroidism.
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
  • One or more laboratory abnormalities:
  • calculated creatinine clearance (Cockroft-Gault) <60mL/min;
  • electrolyte abnormalities according to the Cairo Bishop definition of laboratory TLS.
  • GOT, GPT, γGT > 1.5 x upper limit of normal value;
  • serum bilirubin >1.5 mg/dL.
  • Lactose Intolerance.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Italy10 sites

  • Azienda Spedali Civili

    Brescia, 25100

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, 88100

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • Clinica Ematologica - Università degli Studi

    Genova

  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

    Milan

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • Umberto I di Roma - Dipartimento di Biotecnologie Cellulari ed Ematologia

    Roma, 00161

  • U.O. Ematologia, Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni

    Terni

Other trials in Italy

About this study

Official title: Phase I-II Multicenter Study to Assess the Efficacy and Safety of the Chlorambucil + Lenalidomide Combination and Lenalidomide Maintenance Therapy in Untreated Elderly Pts With CLL. EudraCT Number 2009-013415-35

This is a phase I multicenter, open label study in previously untreated and elderly patients (> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination.

Read the detailed description

All patients will receive six monthly courses of the chlorambucil (C) and lenalidomide (L) schedule consisting of 8 days of C (d1-d8) combined with L given daily until response assessment which will take place 12 weeks from the start (d+1) of course VI, while patients continue their treatment with lenalidomide daily.

In the first phase of the induction phase of the study the dose of L given with C will be gradually escalated to reach the MTD.

Patients who will achieve a response after 6 courses of CL induction phase -PR, CRi, CR

The study was first designed to be a phase I-II trial, yet the second phase of the study was not conducted due to different reasons, among which: poor accrual and lack of interest.

Being tested
Lenalidomide; Chlorambucil
Keywords
CLL, Lenalidomide, Chlorambucil, No previous treatment
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.

  • Lenalidomide; ChlorambucilDrug

    MTD of lenalidomide given in combination with chlorambucil

Study groups in NCT01403246
Study groupRoleWhat they receive
Lenalidomide with ChlorambucilExperimentalNot described
Receives: Drug: Lenalidomide; Chlorambucil

What is being measured

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

  1. Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.

    Measured: At maximum 8 months from induction therapy start

Timeline

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

  1. First posted27 Jul 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Slow patient enrollment and new molecules for chronic lymphoid leukemia, have importantly reduced the interest of conducting the phase II of this study.

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 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01403246
Sponsor's protocol ID
CLL0709
Status last verified
Jan 2019
First submitted
13 Jan 2011
Last updated
12 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide; Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 10 sites in Italy.

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 45 inclusion and 19 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Jan 2019). 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 Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil. (time frame: At maximum 8 months from induction therapy start). 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 NCT01403246.

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 12 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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