Status:
UNKNOWN
Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.
Detailed Description
Inclusion of MDS with IPSS low or int-1 and hemoglobin \< 10/dL. Study drug: Darbepoetin alfa (Aranesp) 500 microg every two weeks subcutaneously during 12 weeks, combined to filgrastim 300 microg tw...
Eligibility Criteria
Inclusion
- MDS of the following subtypes:
- RA, RAS, RAEB with marrow blasts \< 10% (according to FAB),
- RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts \< 13000/mm3 (according to WHO classification)
- Anemia, defined by Hb \< 10 g/dl or RBC transfusion requirement in the absence of other causes of anemia (especially renal failure, iron, or folate deficiency)
- IPSS ≤ 1(ie IPSS low or intermediate 1)
- EPO level \< 500 UI/L
- Ability to perform physical tests of exercise tolerance
- No renal failure (creatinine ≤ 120% normal upper value for the center)
- No underlying severe condition
- ECOG performance status score of 0, 1, or 2
- Must be 18 years of age or older at the time of screening
- Written informed consent
Exclusion
- Therapy related MDS
- MDS with IPSS \> 1 (int 2 or high score)
- Chronic myelomonocytic leukemia with \> 10% marrow blasts or WBC \> 13000/mm3
- Uncontrolled systemic hypertension
- Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia
- Creatinine level \> 120% upper normal value for the center.
- Clinically significant systemic infection or chronic inflammatory disease (eg, rheumatoid arthritis) present at the time of screening
- Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional deficiencies)
- Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease)
- Pregnant (ie, positive βhCG test) or breast feeding female subjects
- Women of childbearing potential and not using adequate contraceptives
- Known positive antibody response to an erythropoietic growth factor
- Known hypersensitivity to darbepoetin alpha or any of its excipients, or to recombinant erythropoietins
- Patient unable to understand the protocol or to be adequately followed up.
- History of seizures
- Previous history of thrombotic events
- Concomitant treatment with thalidomide
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00443339
Start Date
December 1 2006
End Date
July 1 2008
Last Update
May 17 2007
Active Locations (29)
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1
CHU d'Amiens
Amiens, France, 800054
2
CHU d'Angers
Angers, France, 43033
3
CHU d'Avignon
Avignon, France, 84000
4
CH de la Cote Basque
Bayonne, France, 64 100