MDS Current Trials UK

We aim to list an easily understandable description of any MDS clinical trials currently opened to recruitment in the UK.

Patients will be able to read up on the details of these trials and use this information to discuss with their consultants or nurses.

Not all patients can be enrolled in drug trials - as not every patient will fit the necessary inclusion criteria, which need to be followed very strictly. However, if a particular clinical trial drug is considered an option by the haematologist, it is sometimes possible to obtain the drug outside the trial, on the basis of compassionate use.

All the trials listed in this page have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust 

  1. SUB-TYPE OF MDS: All.
  3. NAME OF DRUG: Rigosertib
  4. Aims and benefits: This trial will investigate the survival of MDS patients receiving intravenous Rigosertib after failure of treatment with a Hypomethylating agent (HMA), Azacitidine (aza) or Decitabine (DEC)
  1. Main aims
    Secondary aims
  2. Main basic inclusion criteria:
    • MDS classified as follows:
      RAEB-1 per World Health Organization (WHO) MDS criteria (5% to 9% BM blasts)
      RAEB-2 per WHO MDS criteria (10% to 19% BM blasts)
      RAEB-t per French-American-British (FAB) classification (20% to 30% BM blasts)
    • Diagnosis of MDS confirmed within 8 weeks prior to the Screening Visit
    • At least one type of blood cells being low (cytopenia) (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
    • Progression at any time after initiation of AZA or DEC treatment OR
    • Failure to achieve complete or partial response or hematological improvement (HI)  after at least six cycles of AZA or either four cycles of DEC administered OR
    • Relapse after initial complete or partial response or HI
    • Duration of prior HMA therapy ≤ 9 months
    • Last dose of AZA or DEC within 6 months before the planned date of randomization; however, must be off these treatments for ≥ 4 weeks before randomization
    • Has failed to respond to OR relapsed following OR not eligible for OR opted not to participate in allogeneic stem cell transplantation
    • Off all treatments for MDS (including AZA and DEC) for ≥ 4 weeks before randomization; growth factors (G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated
    • ECOG (how active you are able to be) performance status of 0, 1 or 2
  3. Main basic exclusion criteria:
    • Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation
    • Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine
    • Eligible to receive allogeneic stem cell transplantation
    • Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
    • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure or unstable angina pectoris
    • Active infection not adequately responding to appropriate therapy
    • Known HIV, hepatitis B or hepatitis C
    • Major surgery without full recovery or within 3 weeks before planned randomization;
    • Uncontrolled hypertension
    • New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
    • Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (except prednisone)
    • Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within 4 weeks of planned randomization
    • Investigational therapy within 4 weeks of planned randomization
    • Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
  4. Trial sites/locations and name of physician in charge of trial:
    - UK – Sites:
    Royal Bournemouth Hospital, Bournemouth;
    St Bartholomew's Hospital, Barts Health NHS Trust, London;
    Aberdeen Royal Infirmary, Aberdeen;
    King's College Hospital NHS Foundation Trust, London
    - Europe – Austria (Linz, Salzburg, Vienna), Croatia (Zagreb), France (La Roche Sur Yon, Nîmes, Pierre-Bénite), Spain (Barcelona)
    - USA – Illinois (Chicago), Maryland (Bethesda), Minnesota (Rochester), New York (New York City), and Texas (Dallas, Houston)
  5. More information:

Please read information and always discuss trial information with your own physician.
Download Inspire Facts 2016

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Venetoclax and hypomethylating agents (HMAs) induce high response rates in MDS, including patients after HMA therapy failure

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MDS Fact Sheet

MDS Factsheet for GPs General Practicioners

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Varicella Vaccine in MDS

Urgent Clarification on varicella vaccine policy

Current advice from the UK MDS Forum is not to give the Live Varicella Vaccine to patients with MDS.

Please read below correspondence between Professor Salisbury and Dr George Follows, the latter on behalf of the CLL Forum, on the varicella vaccine policy.
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NICE Guideline

Lenalidomide for treating myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality.

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BSH Guidelines

This is an external link to the home of the British Society for Haematology (BSH). 

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