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

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ClinicalTrials.gov Identifier: NCT01196715
Recruitment Status : Unknown
Verified July 2010 by Barts & The London NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : September 8, 2010
Last Update Posted : March 15, 2012
Sponsor:
Collaborators:
Cancer Research UK
Amgen
Information provided by:
Barts & The London NHS Trust

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Darbepoetin alpha Drug: Filgrastim Procedure: Blood Red Cell Transfusion Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
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).
Study Start Date : November 2010
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Darbepoetin Alfa Drug: Darbepoetin alpha
Aranesp 500 mcg vials once every 2 weeks.
Other Name: Aranesp
Active Comparator: G-CSF Drug: Filgrastim
300 mcg vials twice a week, 3-4 days apart
Other Name: Neupogen
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
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.
Other Name: Blood transfusion.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life [ 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

  2. Haemoglobine response [ 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

  3. Quality of Life [ 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

  4. Quality of Life [ 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

  5. Quality of Life [ 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

  6. Quality of Life [ 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

  7. Haemoglobine response [ 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

  8. Haemoglobine response [ 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

  9. Haemoglobine response [ 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

  10. Haemoglobine response [ 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

  11. Haemoglobine response [ 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

  12. Haemoglobine response [ 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

  13. Haemoglobine response [ 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

  14. Haemoglobine response [ 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


Secondary Outcome Measures :
  1. Utility of prognostic factor and predictive factor assessment [ Time Frame: every week ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  2. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 4 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  3. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 8 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  4. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 12 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  5. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 16 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  6. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 20 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  7. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 24 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  8. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 36 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

  9. Utility of prognostic factor and predictive factor assessment [ Time Frame: week 52 ]
    To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196715


Contacts
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Contact: Eva Controle, BSc 00442078828499 ext 8499 e.controle@qmul.ac.uk
Contact: REGIME Coordinators 00442078828499 ext 8499 regime@qmcr.qmul.qc.uk

Locations
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United Kingdom
Birmingham Cancer Research UK Clinical Trial Unit
Birmingham, United Kingdom, B15 2TT
Contact: Data Manager    00441214159132    regime@trials.bham.ac.uk   
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Contact: Sarah Knight       sarah.knight@bartsandthelondon.nhs.uk   
Principal Investigator: Samir G Agrawal         
CECM Institute of Cancer
London, United Kingdom, EC1M 6BQ
Contact: Eva Controle, BSc    00442078828499    e.controle@qmul.ac.uk   
Contact: REGIME Coordinators    00442078828499    regime@qmcr.qmul.ac.uk   
King's College Hospital Haematoloy Laboratory
London, United Kingdom, SE5 9RS
Contact: Aloysius Ho    00442077374000 ext 4153      
Sponsors and Collaborators
Barts & The London NHS Trust
Cancer Research UK
Amgen
Investigators
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Study Director: Samir G Agrawal, MRCP FRCPath PhD Barts and The London NHS Trust
More Information
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Additional Information:

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Responsible Party: Dr Samir G. Agrawal, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01196715    
Other Study ID Numbers: MDS201001
2009-017462-23 ( EudraCT Number )
CRUK/08/009 ( Other Grant/Funding Number: CR-UK )
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: July 2010
Keywords provided by Barts & The London NHS Trust:
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
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms
Darbepoetin alfa
Hematinics