NCT00443339

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

29 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 17, 2007

Status Verified

March 1, 2007

First QC Date

March 4, 2007

Last Update Submit

May 15, 2007

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndromes with IPSS Low or Int-1Anemia

Outcome Measures

Primary Outcomes (1)

  • Erythroid response at 12 weeks according to IWG 2000 (major and minor hematologic improvement) and IWG 2006 criteria

Secondary Outcomes (5)

  • Tolerability and safety of darbepoetin alpha

  • Rate of progression to more severe MDS, with higher IPSS (int 2 or high), or to AML during the treatment and follow-up periods

  • Overall survival

  • Quality of life during the study, using the FACT-An and SF36 questionnaires by comparison to pre-treatment values

  • Overall physical performance as measured by VO2max, 6 minute walk test and the "short physical performance battery" test

Interventions

DarbepoetinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

CHU d'Amiens

Amiens, 800054, France

RECRUITING

CHU d'Angers

Angers, 43033, France

RECRUITING

CHU d'Avignon

Avignon, 84000, France

RECRUITING

CH de la Cote Basque

Bayonne, 64 100, France

RECRUITING

CHU de Brest - Hopital Morvan

Brest, 29 609, France

RECRUITING

CHU de Caen

Caen, 14033, France

RECRUITING

Hopital Percy

Clamart, 92140, France

RECRUITING

Hopital Henri Mondor

Créteil, 94010, France

RECRUITING

CHU de Dijon

Dijon, 21034, France

RECRUITING

CHU Albert Michallon

Grenoble, 38043, France

RECRUITING

CHRU Hurriez

Lille, 59057, France

RECRUITING

CHRU Limoges

Limoges, 87046, France

RECRUITING

Hopital Edouard Herriot

Lyon, 69437, France

RECRUITING

Hopital Paoli Calmette

Marseille, 13273, France

RECRUITING

Hopital Hotel Dieu

Nantes, 44093, France

RECRUITING

CHU Archet

Nice, 06202, France

RECRUITING

Hopital Hotel Dieu

Paris, 75181, France

RECRUITING

Hopital Hotel Dieu

Paris, 75181, France

RECRUITING

Hopital St Louis

Paris, 75475, France

RECRUITING

Hopital Saint Antoine

Paris, 75571, France

RECRUITING

Hopital Cochin

Paris, 75679, France

RECRUITING

Hopital Jean-Bernard

Poitiers, 86021, France

RECRUITING

CHU Robert Debre

Reims, 51092, France

RECRUITING

CHU Pontchaillou

Rennes, 35033, France

RECRUITING

Hopital Henri Becquerel

Rouen, 76038, France

RECRUITING

Hopital Hautepierre

Strasbourg, 67098, France

RECRUITING

Hopital Purpan

Toulouse, 31031, France

RECRUITING

Hopital Bretonneau

Tours, 37044, France

RECRUITING

CHU Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (1)

  • Kelaidi C, Beyne-Rauzy O, Braun T, Sapena R, Cougoul P, Ades L, Pillard F, Lamberto C, Charniot JC, Guerci A, Choufi B, Stamatoullas A, Slama B, De Renzis B, Ame S, Damaj G, Boyer F, Chaury MP, Legros L, Cheze S, Testu A, Gyan E, Bene MC, Rose C, Dreyfus F, Fenaux P. High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM. Ann Hematol. 2013 May;92(5):621-31. doi: 10.1007/s00277-013-1686-4. Epub 2013 Jan 29.

    PMID: 23358617DERIVED

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Charikleia KELAIDI, MD

    Groupe Francophone des Myelodysplasies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charikleia KELAIDI, MD

CONTACT

0033148957051charikleia .kelaidi@avc.aphp.fr

Fatima-Zohra HAMZA, RCA

CONTACT

0033148955890fatima.hamza@avc.aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2007

First Posted

March 6, 2007

Study Start

December 1, 2006

Study Completion

July 1, 2008

Last Updated

May 17, 2007

Record last verified: 2007-03

Locations

FR(29)