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Imerge (Imetelstat) – Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

Imerge (Imetelstat)

  1. SUB-TYPE OF MDS: Low risk MDS patients
  2. SEVERITY OF MDS: IPSS Low or Intermediate-1 risk MDS
  3. NAME OF DRUG: Imetelstat
  4. Aims and benefits: This phase 2/3 study aims to determine the effectiveness of Imetelstat in transfusion dependent low risk MDS patients who have either lost their response or not responded to erythropoiesis-stimulating agent (ESA) treatment. The study has 2 parts. Part 1 seeks to determine the effectiveness and safety of Imetelstat, looking more closely at improvement in blood counts and reduction in transfusion requirements. Part 2 is double-blind and randomised to compare the effectiveness of Imetelstat with placebo.
  5. Primary outcome:To determine the percentage of patients who have not required a red cell transfusion in an 8 week period.
  6. Secondary outcome:To determine adverse effects, red cell transfusion independence, improvement in blood counts, progression to acute myeloid leukaemia and overall survival.

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Luspatercept in long term follow-up – Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

Luspatercept in long term Follow up

  1. SUB-TYPE OF MDS:Low risk MDS patients who have participated in other Luspatercept clinical trials
  2. SEVERITY OF MDS: IPSS-R Very Low, Low or Intermediate Risk MDS
  3. NAME OF DRUG: Luspatercept
  4. Aims and benefits: To determine the long term safety of Luspatercept. This is a phase 3 single arm trial that is divided into 3 phases: the Transition Phase (period prior to enrollement into the study), Treatment Phase (for patients receiving Luspatercept treatment) and Follow-up Phase (Patients are observed for up to 5 years from start of Luspatercept or 3 years from the last dose of Luspatercept).
  5. Primary outcome:To determine adverse events over the period of observation as well as the incidence of disease progression and the development of other malignancies.
  6. Secondary outcome:To determine the overall survival in this patient group.

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UCART123 – Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

UCART123

  1. SUB-TYPE OF MDS:Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML), including patients with CD123 positive AML secondary to MDS
  2. SEVERITY OF MDS: AML
  3. NAME OF DRUG: UCART targeting CD123 positive leukaemia cells
  4. Aims and benefits: This is a phase 1 first in human study to determine the safety and effectiveness of multiple infusions of UCART123 (specially engineered T-cells that target leukaemia cells that express CD123).

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RFUSIN2-AML1 – Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

RFUSIN2-AML1

  1. SUB-TYPE OF MDS:Patients with primary or secondary AML acute myeloid leukaemia (including disease
    transformed from Myelodysplastic Syndrome) who fail to enter complete morphological remission or have persistence of cytogenetic abnormality following intensive combination chemotherapy at day+100 post-transplant
  2. SEVERITY OF MDS: AML
  3. NAME OF DRUG: Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) that express
    B7.1 (CD80) and IL-2 (AML cell vaccine)
  4. Aims and benefits: This is a phase 1 study aimed at determining the safety of the AML cell vaccine.

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ACE-536-MDS-002 (Luspatercept) – Clinical Trial Open to Recruitment

Written by

MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

ACE-536-MDS-002 (Luspatercept)

  1. SUB-TYPE OF MDS:Lower Risk MDS patients who require red cell transfusions but have not received Erythropoietin
  2. SEVERITY OF MDS: IPSS-R Very Low, Low or Intermediate Risk MDS
  3. NAME OF DRUG: Luspatercept
  4. Aims and benefits: To compare the safety and efficacy of Luspatercept versus epoetin alfa for treating anaemia in patients who require red cell transfusions.
    Luspatercept promotes red blood cell formation by regulating the growth of red blood cells during the late-stage of their development. It works differently to erythropoietin.
    This is a Phase 3 Randomized Study between Luspatercept and Epoetin alfa.

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FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

FG-4592-082 (Roxadustat)

  1. SUB-TYPE OF MDS:Lower Risk MDS With Low Red Blood Cell Transfusion Burden
  2. SEVERITY OF MDS: IPSS-R classification very low, low or intermediate risk with <5% blasts
  3. NAME OF DRUG: Roxadustat
  4. Aims and benefits: To determine whether Roxadustat is safe and effective in treating anaemia in patients with Primary Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.
    Roxadustat is an oral preparation that stimulates erythropoiesis (production of red cells) by increasing the body’s production of the hormone erythropoietin and it regulates the way in which the body uses iron. This study is a Phase 3 Randomized Double-Blind Placebo-Controlled Study in which there is a treatment period of 52 weeks and a 4 week end of treatment assessment.

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PANTHER: Clinical Trial Open to Recruitment

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MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

PANTHER

  1. SUB-TYPE OF MDS:Higher risk MDS, CMML, low blast count AML
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: Azacitidine, Pevonedistat
  4. Aims and benefits: Pevonedistat prevents the activity of a specific enzyme (Nedd8 activating enzyme) and thus may result in the inhibition of tumour cell growth and survival. This is a phase 3 study to determine if combining Pevonedistat with Azacitidine improves survival when compared with single agent Azacitidine.

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BRIGHT: Clinical Trial Open to Recruitment

Written by

MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

BRIGHT

  1. SUB-TYPE OF MDS:Previously untreated higher-risk MDS, AML or CMML
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: Glasdegib, Azacitidine
  4. Aims and benefits: PGlasdegib disrupts cancer stem cell survival. This has the potential to reduce the development of drug resistance and prevent relapse. This is a Phase 1b study aimed at determining the safety and effectiveness of Glasdegib in combination with Azacitidine in this specific patient group.

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CPDR001X2105: Clinical Trial Open to Recruitment

Written by

MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

CPDR001X2105

  1. SUB-TYPE OF MDS:High risk MDS and AML, not suitable for induction chemotherapy or haemopoietic stem cell transplant
  2. SEVERITY OF MDS: High Risk MDS
  3. NAME OF DRUG: PDR001, MBG453, Decitabine
  4. Aims and benefits: PDR001 is a monoclonal antibody that functions to block the activity of PD-1 (programmed cell death protein 1) thus allowing T-cells to recognise and target cancer cells. MBG453 is a monoclonal antibody that binds to a specific protein found on the surface of T-cells thus allowing the T-cell to function normally against cancer cells by reducing tumour growth. This is a phase 1b study aimed at determining the safety and tolerability of the study drugs alone and in combination with decitabine. The study also aims to determine the recommended doses of each of these drugs.

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RFUSIN2AML2: Clinical Trial Open to Recruitment

Written by

MDS Patient Support

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

RFUSIN2AML2

  1. SUB-TYPE OF MDS: High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
  2. SEVERITY OF MDS: High Risk MDS
  3. NAME OF DRUG: B7.1 (CD80)/IL-2 Immune Gene Therapy
  4. Aims and benefits: This is a phase I study intended to identify the safety and tolerability of an "AML Cell Vaccine" given to eligible MDS and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

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