Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

Myelodysplastic Syndrome Clinical Trial

Official title:

Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01039350
• Other study ID #: GEE200401
• Secondary ID: 2005-002414-38
• Status: Terminated
• Phase: Phase 2
• First received: December 23, 2009
• Last updated: January 12, 2010
• Start date: February 2006
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit.

Description:

This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit. Darbepoetin alfa will be initiated at a dose of 300 mcg QW SC over a period of 8 weeks. After 8 weeks, erythroid response will be evaluated, and treatment algorithm adapted to it.

The study treatment period will last for a maximum of 24 weeks. The treatment will end at the start of week 24. If the scheduled 24-week treatment period is not completed, it will end during the week of the last administration of the study drug.

The follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the last dose of darbepoetin alfa.

Subjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1 risk).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age ³ 18 years

• Low or intermediate-1 risk MDS according to IPSS, and FAB classification of RA, RARS, or RAEB with blasts £ 10%

• Predictive variables of good response (serum erythropoietin levels < 500 IU/l and transfusion requirements < 2 packed RBC/month over the preceding 2 months)

• Anaemia (Hb £ 10 g/dL), confirmed in the 14 days before day 1 of the study

• Life expectancy of at least 6 months

• ECOG Performance status score of 0, 1, or 2

• Subject must sign and date the Informed Consent (approved by a Clinical Research Ethics Committee - CREC), before any study-specific procedure is performed

Exclusion Criteria:

• Known history of convulsive disorders

• Poorly controlled hypertension (diastolic blood pressure > 100 mmHg) at screening

• Inadequate liver function (total bilirubin > two times the upper limit of the normal range (ULN), and liver enzymes (ALT, AST) > two times ULN)

• Inadequate renal function (serum creatinine concentration > 2 mg/dL)

• Ferritin < 100 ng/ml or transferrin saturation index (TSI) < 16%; Vitamin B12 deficiency (< 200 pg/ml) or folate deficiency (< 2 ng/ml)

• Clinically-relevant haemorrhages

• Haemolytic anaemia

• Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia

• Clinically significant systemic infection or chronic inflammatory disease present at time of screening

• Any concomitant therapy used to treat MDS (including other growth factors than those described as part of this protocol, chemotherapy, antibody-based cancer treatment, hormonal therapy, interferon, and interleukins)

• Treatment with rHuEPO or darbepoetin alfa over the 4 weeks prior to Day 1 of the study

• More than 2 RBC transfusions over the 28 days prior to Day 1 of the study

• Pregnant or breast feeding women

• Subjects of childbearing-potential who do not take adequate contraceptive measures, in the opinion of the investigator

• Known hypersensitivity to any mammal-derived recombinant product

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Darbepoetin alfa
Darbepoetin alfa will be initiated at a weekly (QW) subcutaneous dose of 300 mcg over 8 weeks.

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital de Cruces	Barakaldo	Bilbao
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Duran i Reynals	Barcelona
Spain	Hospital Vall D´Hebron	Barcelona
Spain	Hospital General Yagüe	Burgos
Spain	Hospital Universitario Puerta del Mar	Cádiz
Spain	Complejo Hospitalario Universitario Juan Canalejo	La Coruña
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Virgen del Puerto	Plasencia	Caceres
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Universitario La Fé	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon

Country where clinical trial is conducted

Spain, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving an erythroid response during the 24-week treatment period.		weeks 8; 12; 16 and 24	No
Secondary	Time to erythroid response and time it is maintained.		week 24	No
Secondary	Proportion of non-responders to darbepoetin alfa who obtain an erythroid response after the addition of Filgrastim		weeks 8, 12, 16 and 24	No
Secondary	Proportion of patients receiving RBC transfusions (more than 1 unit) from week 5 to 24, inclusive		weeks 8; 12; 16 and 24	No
Secondary	Score changes in the FACT-Fatigue quality-of-life scale between the baseline visit, and weeks 8, 16, 24, and the end of the study.		weeks 8; 16 and 24	No
Secondary	Number of morphological and cytogenetic disorders at baseline and end of treatment		week 24	No
Secondary	Incidence of adverse events and serious adverse events		weeks 8; 12; 16 and 24	Yes
Secondary	Proportion of patients with haemoglobin values over 12 g/dL at any time during the study		weeks 8; 12; 16 and 24	Yes