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Chronic Lymphocytic LeukaemiaPhase 2RESPeCTNCT01127542

RESPeCT: Revlimid Early Stage Poor Prognosis Chronic Lymphocytic Leukaemia (CLL) Trial

A Phase 2 study testing Lenalidomide in people with Chronic Lymphocytic Leukaemia, run by The Christie NHS Foundation Trust at 9 sites in United Kingdom.

Terminated

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

Official record
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Trial summary

The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or Rai stage 0/I). Standard management of such patients is observation, and with median age at diagnosis of 72 and median time to progression of >5-10 years, many will never require treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukaemia
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
1 participants
Where
9 sitesUnited Kingdom
Study dates
May 2010to Dec 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

  • Binet stage A CLL
  • 2 or more risk factors:
  • Unmutated IgVH locus (≥98% homology to germline sequence)
  • CD38 expression (>7%)
  • Deletion of chromosome 11q22 (>20% by FISH)
  • Deletion of chromosome 17p13 (>10% by FISH)
Show all 13Show fewer
  • Over 18 years old
  • Capable to provide written informed consent
  • ECOG performance status < 2
  • Life expectancy > 2 years
  • Must agree to not share lenalidomide with someone else
  • Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment.
  • Female subjects of childbearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan.

Who cannot join

  • Current or recent (within the last 1 month) participation in another clinical trial investigating the action of an investigational medicinal product for the treatment of CLL
  • Pregnant or lactating
  • Known positivity for human immunodeficiency virus (HIV) types 1 or 2
  • Prior history of malignancies, other than CLL, unless the subject was treated with curative intent and has been free of the disease for ≥3 years. Exceptions include the following:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
Show all 18Show fewer
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Significantly abnormal renal or hepatic function (creatinine clearance < 60ml/min, serum aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN), serum bilirubin > 34μmol/l)
  • Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected.
  • Peripheral neuropathy (grade ≥ 2)
  • Previous treatment for CLL
  • Previous treatment with Thalidomide or immunomodulatory derivative drugs (including Lenalidomide)
  • Treatment with corticosteroids (for CLL or other indications) < 28 days from study entry
  • Evidence of Richter's transformation
  • Unsupported absolute neutrophil count < 1x109/l or platelet count < 50x10*9/l not due to CLL
  • Active autoimmune haemolytic anaemia or thrombocytopenia
  • Any other medical or psychological condition that in the view of the investigator would be likely to impact compliance with the protocol or interfere with trial treatment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United Kingdom9 sites

  • Heart of England NHS Foundation Trust

    Birmingham, B9 5SS

  • The Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • St James's University Hospital

    Leeds, LS9 7TF

  • The Royal Liverpool and Broadgreen University Hospital

    Liverpool, L7 8XP

  • King's College Hospital

    London, SE5 9RS

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Mid Yorkshire Hospitals NHS Trust

    Wakefield, WF1 4DG

Other trials in United Kingdom

About this study

Official title: A Single Arm Phase II Study to Investigate the Use of Lenalidomide in the Treatment of Patients With Early Stage CLL Associated With Poor Prognostic Factors

The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or Rai stage 0/I). Standard management of such patients is observation, and with median age at diagnosis of 72 and median time to progression of >5-10 years, many will never require treatment. In contrast, a proportion of patients have more aggressive disease, and over the last decade, a number of molecular factors have been identified that may be used to identify patients with poor prognosis disease . Each is associated with shortened time to treatment (typically less than 3 years in patients with 2 of more factors), reduced survival, with in the case of p53/ATM inactivation, resistance to treatment. Whether it is possible to improve the outcome of patients with CLL and adverse prognostic factors by early intervention with treatment is unknown. Several trials in the 1980's demonstrated that treatment of stage A CLL with conventional chemotherapy (chlorambucil) did not alter the natural history of the disease, although none of these studies stratified patients according to risk. The choice of alternative potential therapeutic agents is limited; they should be effective in patients with adverse prognostic factors, have acceptable toxicity, be able to overcome the drug resistance associated with p53/ATM inactivation and ideally be orally administered. Two recent phase II trials have demonstrated that Lenalidomide is effective in the treatment of relapsed/refractory disease. Importantly, both studies included a high proportion of patients with adverse prognostic factors including p53 inactivation. The principle objective of this study is to investigate the efficacy of Lenalidomide in achieving disease response (complete remission and clearance of minimal residual disease) in patients with poor risk early stage disease, together with assessment of safety and tolerability.

Being tested
Lenalidomide
Medical subject headings
Leukemia, B-Cell

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid, CC-5013

    Daily oral lenalidomide. Starting dose of 2.5mg daily, escalating to target dose of 10mg daily.

Study groups in NCT01127542
Study groupRoleWhat they receive
Lenalidomide for early stage poor prognosis CLLExperimentalNot described
Receives: Drug: Lenalidomide

What is being measured

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

  1. Complete Remission with clearance of Minimal Residual Disease (MRD)

    Measured: 6 months (or earlier if clinically indicated)

Secondary outcomes (3)

  1. Event free survival

    Defined as interval from the first treatment day to the first sign of disease progression, treatment for relapse or death (whichever occurs first).

    Measured: Treatment/ progression/ death details collected at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up)

  2. Safety & tolerability of treatment (occurrence of adverse events)

    Adverse events will be monitored according to NCI CTCAE v3 from screening until 1 month after treatment discontinuation/ trial closure. Adverse event data will be captured at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance). Adverse event data will be assessed by blood tests, physical exam/ vital signs and pregnancy testing.

    Measured: Assessed at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up)

  3. Time to next treatment

    Defined as interval between first treatment day on the study protocol to the first day of the next course of CLL therapy following disease progression.

    Measured: Treatment details collected at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up)

Timeline

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

  1. First posted21 May 2010 (estimated)
  2. Study startMay 2010
  3. Study completionDec 2011

Why it stopped: Potential safety issue of second primary malignancies in patients treated with lenalidomide.

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127542
Sponsor's protocol ID
09_DOG06_99
Other IDs
2009-011078-14, ISRCTN, 2009
Acronym
RESPeCT
Status last verified
Dec 2011
First submitted
19 May 2010
Last updated
5 Dec 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Chronic Lymphocytic Leukaemia, run by The Christie NHS Foundation Trust at 9 sites in United Kingdom.

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 13 inclusion and 18 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 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. 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 stopped early (reason given: Potential safety issue of second primary malignancies in patients treated with lenalidomide.). Results are not available in the source record.

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?

Complete Remission with clearance of Minimal Residual Disease (MRD) (time frame: 6 months (or earlier if clinically indicated)). 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 NCT01127542.

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 5 Dec 2011.

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