Status:
COMPLETED
Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Cancer Research UK
Amgen
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 givi...
Eligibility Criteria
Inclusion
- 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)
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01196715
Start Date
November 1 2010
End Date
October 31 2015
Last Update
February 6 2025
Active Locations (4)
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1
Birmingham Cancer Research UK Clinical Trial Unit
Birmingham, United Kingdom, B15 2TT
2
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
3
CECM Institute of Cancer
London, United Kingdom, EC1M 6BQ
4
King's College Hospital Haematoloy Laboratory
London, United Kingdom, SE5 9RS