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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-01

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Darbepoetin Alfa

Group Type ACTIVE_COMPARATOR

Darbepoetin alpha

Intervention Type DRUG

Aranesp 500 mcg vials once every 2 weeks.

G-CSF

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Blood Red Cell Transfusion

Intervention Type PROCEDURE

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.

Interventions

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Darbepoetin alpha

Aranesp 500 mcg vials once every 2 weeks.

Intervention Type DRUG

Filgrastim

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Aranesp Neupogen Blood transfusion.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No