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CompletedNCT01196715REGIMEUpdated Feb 6, 2025

Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes

A Phase 3 interventional study of Darbepoetin alpha and Filgrastim in Myelodysplastic Syndrome, sponsored by Barts & The London NHS Trust. Completed at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Barts & The London NHS Trust · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
  • Incidence of disease progression
  • Overall Survival
03

In context

Myelodysplastic Syndromes

2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.

This study's planned enrollment of 360 is above the median of 39 across 1,771 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Barts & The London NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females aged over 18 years, (no upper age limit)
  2. ECOG performance status 0-2
  3. Life expectancy more than 6 months

  4. A confirmed diagnosis of MDS - WHO type:

    • refractory anaemia (RA)
    • hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine)
    • refractory anaemia with ring sideroblasts (RARS)
    • refractory cytopenia with multilineage dysplasia
    • myelodysplastic syndrome unclassifiable
  5. IPSS low or Int-1, but with BM blasts less than 5%
  6. A haemoglobin concentration of less than 10g/dl and/or red cell transfusion dependence
  7. Able to understand the implications of participation in the Trial and give written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. MDS with bone marrow blasts greater or equal than 5%
  2. Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome
  3. Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l)
  4. Therapy-related MDS
  5. Splenomegaly, with spleen greater or equal than 5 cm from left costal margin
  6. Platelets less than 30x109/l
  7. Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges
  8. Women who are pregnant or lactating.
  9. 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
  10. Females of childbearing potential must have a negative pregnancy test prior to starting the study.
  11. Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease
  12. Previous serious adverse events to the study medications or its components
  13. Patients who have had previous therapy with ESAs ± G-CSF within 4 weeks of study entry
  14. Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another CTIMP.
  15. Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.
  16. Patients with malignancy requiring active treatment (except hormonal therapy).
  17. Patients with a history of seizures
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Active comparator
    Darbepoetin Alfa

    Drug: Darbepoetin alpha

  • Active comparator
    G-CSF

    Drug: Filgrastim

  • Active comparator
    Best Supportive Care

    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

    Procedure: Blood Red Cell Transfusion

Interventions

  • DrugDarbepoetin alpha

    Aranesp 500 mcg vials once every 2 weeks.

    Also known as: Aranesp

  • DrugFilgrastim

    300 mcg vials twice a week, 3-4 days apart

    Also known as: Neupogen

  • ProcedureBlood Red Cell 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.

    Also known as: Blood transfusion.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: weeks 0

  2. 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

    Time frame: week 0

  3. 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

    Time frame: weeks 12

  4. 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

    Time frame: weeks 24

  5. 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

    Time frame: weeks 36

  6. 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

    Time frame: weeks 52

  7. 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

    Time frame: week 4

  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

    Time frame: week 8

  9. 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

    Time frame: week 12

  10. 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

    Time frame: week 16

  11. 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

    Time frame: week 20

  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

    Time frame: week 24

  13. 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

    Time frame: week 36

  14. 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

    Time frame: week 52

Secondary outcomes

  1. 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.

    Time frame: every week

  2. 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.

    Time frame: week 4

  3. 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.

    Time frame: week 8

  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.

    Time frame: week 12

  5. 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.

    Time frame: week 16

  6. 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.

    Time frame: week 20

  7. 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.

    Time frame: week 24

  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.

    Time frame: week 36

  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.

    Time frame: week 52

07

Study locations

4 sites
  • Birmingham Cancer Research UK Clinical Trial Unit
    Birmingham, B15 2TT, United Kingdom
  • St Bartholomew's Hospital
    London, EC1A 7BE, United Kingdom
  • CECM Institute of Cancer
    London, EC1M 6BQ, United Kingdom
  • King's College Hospital Haematoloy Laboratory
    London, SE5 9RS, United Kingdom
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2010 to primary completion in Oct 2015, 59 months.

Of 49 phase 3 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 95. This study's 59 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2010
First posted
Sep 8, 2010
StartActual
Nov 1, 2010
Primary completionActual
Oct 31, 2015
CompletionActual
Oct 31, 2015
Last update
Feb 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01196715
Lead sponsor
Barts & The London NHS Trust
Collaborators
Cancer Research UK, Amgen
Responsible party
Sponsor
First posted
Sep 8, 2010
Start date
Nov 1, 2010
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015
Last update
Feb 6, 2025

Study contacts

Samir G Agrawal, MRCP FRCPath PhD
study director · Barts and The London NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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