Myelodysplastic SyndromePhase 3REGIMENCT01196715
Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes
A Phase 3 study testing Darbepoetin alpha, Filgrastim and Blood Red Cell Transfusion in people with Myelodysplastic Syndrome, run by Barts & The London NHS Trust at 4 sites in United Kingdom.
Trial summary
REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS). After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Darbepoetin alpha, Filgrastim and Blood Red Cell Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Nov 2010to 31 Oct 2015
- Phase
- Phase 3
- 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
- Males and females aged over 18 years, (no upper age limit)
- ECOG performance status 0-2
- Life expectancy more than 6 months
- A confirmed diagnosis of MDS - WHO type:
- refractory anaemia (RA)
- hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine)
Show all 12Show fewer
- refractory anaemia with ring sideroblasts (RARS)
- refractory cytopenia with multilineage dysplasia
- myelodysplastic syndrome unclassifiable
- IPSS low or Int-1, but with BM blasts less than 5%
- A haemoglobin concentration of less than 10g/dl and/or red cell transfusion dependence
- Able to understand the implications of participation in the Trial and give written informed consent.
Who cannot join
- MDS with bone marrow blasts greater or equal than 5%
- Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
- Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l)
- Therapy-related MDS
- Splenomegaly, with spleen greater or equal than 5 cm from left costal margin
- Platelets less than 30x109/l
Show all 17Show fewer
- Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges
- Women who are pregnant or lactating.
- Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- Females of childbearing potential must have a negative pregnancy test prior to starting the study.
- Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease
- Previous serious adverse events to the study medications or its components
- Patients who have had previous therapy with ESAs ± G-CSF within 4 weeks of study entry
- Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another CTIMP.
- Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.
- Patients with malignancy requiring active treatment (except hormonal therapy).
- Patients with a history of seizures
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Birmingham Cancer Research UK Clinical Trial Unit
Birmingham, B15 2TT
St Bartholomew's Hospital
London, EC1A 7BE
CECM Institute of Cancer
London, EC1M 6BQ
King's College Hospital Haematoloy Laboratory
London, SE5 9RS
About this study
Official title: REGIME: A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha, With or Without Recombinant Human Granulocyte Colony Stimulating Factor, Versus Best Supportive Care in Patients With Low-risk Myelodysplastic Syndromes (MDS).
REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS).
After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend the clinic twice more, at week 36 and 52.
Patients will be followed for a further 5 years to record loss of response, transformation to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Darbepoetin alpha, Filgrastim, Blood Red Cell Transfusion
- Keywords
- Quality of Life, Erythroid response, disease progression, survival, Overall erythroid response at 24 weeks, Quality of life at 24 weeks, Quality of life at 12, 36 and 52 weeks, Overall erythroid response at 12 and 52 weeks, Incidence of disease progression, Overall Survival
- Medical subject headings
- Myelodysplastic Syndromes, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alphaDrug
Also called Aranesp
Aranesp 500 mcg vials once every 2 weeks.
FilgrastimDrug
Also called Neupogen
300 mcg vials twice a week, 3-4 days apart
Blood Red Cell TransfusionProcedure or surgery
Also called Blood transfusion.
Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl or such that the patient is never excessively symptomatic, according to local transfusion guidelines/policy.
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin Alfa | Active comparator | Not described Receives: Drug: Darbepoetin alpha |
| G-CSF | Active comparator | Not described Receives: Drug: Filgrastim |
| Best Supportive Care | Active comparator | Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl Receives: Procedure: Blood Red Cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: weeks 0
Haemoglobin response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 0
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: weeks 12
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: weeks 24
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: weeks 36
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: weeks 52
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 4
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 8
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 12
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 16
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 20
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 24
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 36
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Measured: week 52
Secondary outcomes (9)
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: every week
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 4
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 8
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 12
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 16
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 20
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 24
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 36
Utility of prognostic factor and predictive factor assessment
To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study start1 Nov 2010
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Amgen
- Responsible party
- Sponsor
- Investigators
- Samir G Agrawal, MRCP FRCPath PhD, Study director, Barts and The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196715
- Sponsor's protocol ID
- MDS201001
- Other IDs
- 2009-017462-23, CRUK/08/009, 2009
- Acronym
- REGIME
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2010
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGIME: A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha, With or Without Recombinant Human Granulocyte Colony Stimulating Factor, Versus Best Supportive Care in Patients With Low-risk Myelodysplastic Syndromes (MDS).
- ClinicalTrials.gov ID
- NCT01196715
- Acronym / sponsor ID
- REGIME / MDS201001
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Quality of Life, Erythroid response, disease progression, survival, Overall erythroid response at 24 weeks, Quality of life at 24 weeks, Quality of life at 12, 36 and 52 weeks, Overall erythroid response at 12 and 52 weeks
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Cancer Research UK, Amgen
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS).
After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend the clinic twice more, at week 36 and 52.
Patients will be followed for a further 5 years to record loss of response, transformation to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin Alfa | Active comparator | Drug: Darbepoetin alpha |
| G-CSF | Active comparator | Drug: Filgrastim |
| Best Supportive Care | Active comparator | Procedure: Blood Red Cell TransfusionRed cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females aged over 18 years, (no upper age limit)
- ECOG performance status 0-2
- Life expectancy more than 6 months
- A confirmed diagnosis of MDS - WHO type:
- IPSS low or Int-1, but with BM blasts less than 5%
Key exclusion criteria (17 listed)
- MDS with bone marrow blasts greater or equal than 5%
- Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
- Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l)
- Therapy-related MDS
- Splenomegaly, with spleen greater or equal than 5 cm from left costal margin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin alphaAlso: AranespAranesp 500 mcg vials once every 2 weeks. | Drug | Darbepoetin Alfa |
| FilgrastimAlso: Neupogen300 mcg vials twice a week, 3-4 days apart | Drug | G-CSF |
| Blood Red Cell TransfusionAlso: Blood transfusion.Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl or such that the patient is never excessively symptomatic, according to local transfusion guidelines/policy. | Procedure or surgery | Best Supportive Care |
Primary outcome
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: weeks 0
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobin response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 0
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: weeks 12
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: weeks 24
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: weeks 36
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: weeks 52
To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 4
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 8
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 12
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 16
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 20
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 24
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 36
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Haemoglobine response - To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
Time frame: week 52
To compare the haemoglobin response of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone
9 secondary outcomes
Utility of prognostic factor and predictive factor assessment
Time frame: every week
Utility of prognostic factor and predictive factor assessment
Time frame: week 4
Utility of prognostic factor and predictive factor assessment
Time frame: week 8
Utility of prognostic factor and predictive factor assessment
Time frame: week 12
Utility of prognostic factor and predictive factor assessment
Time frame: week 16
Utility of prognostic factor and predictive factor assessment
Time frame: week 20
Utility of prognostic factor and predictive factor assessment
Time frame: week 24
Utility of prognostic factor and predictive factor assessment
Time frame: week 36
Utility of prognostic factor and predictive factor assessment
Time frame: week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- CR-UK funded Trial researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir G Agrawal, MRCP FRCPath PhD study director
Barts and The London NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin alpha, Filgrastim and Blood Red Cell Transfusion in people with Myelodysplastic Syndrome, run by Barts & The London NHS Trust at 4 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 12 inclusion and 17 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone (time frame: weeks 0). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.