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

January 12, 2010 updated by: Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall d´hebron
      • Barcelona, Spain, 08907
        • Hospital Duran I Reynals
      • Burgos, Spain, 09005
        • Hospital General Yagüe
      • Cádiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario Juan Canalejo
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de Octubre
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Central de Asturias
    • Bilbao
      • Barakaldo, Bilbao, Spain, 48903
        • Hospital de Cruces
    • Caceres
      • Plasencia, Caceres, Spain, 10600
        • Hospital Virgen del Puerto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving an erythroid response during the 24-week treatment period.
Time Frame: weeks 8; 12; 16 and 24
weeks 8; 12; 16 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to erythroid response and time it is maintained.
Time Frame: week 24
week 24
Proportion of non-responders to darbepoetin alfa who obtain an erythroid response after the addition of Filgrastim
Time Frame: weeks 8, 12, 16 and 24
weeks 8, 12, 16 and 24
Proportion of patients receiving RBC transfusions (more than 1 unit) from week 5 to 24, inclusive
Time Frame: weeks 8; 12; 16 and 24
weeks 8; 12; 16 and 24
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.
Time Frame: weeks 8; 16 and 24
weeks 8; 16 and 24
Number of morphological and cytogenetic disorders at baseline and end of treatment
Time Frame: week 24
week 24
Incidence of adverse events and serious adverse events
Time Frame: weeks 8; 12; 16 and 24
weeks 8; 12; 16 and 24
Proportion of patients with haemoglobin values over 12 g/dL at any time during the study
Time Frame: weeks 8; 12; 16 and 24
weeks 8; 12; 16 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon

Investigators

  • Principal Investigator: Ana M Villegas, MD, Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Anticipated)

July 1, 2008

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEE200401
  • 2005-002414-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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