Back to results

Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

Primary Purpose

Myelodysplastic Syndromes

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Darbepoetin

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplastic syndromes with IPSS Low or Int-1, Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00443339

First Posted

March 4, 2007

Last Updated

May 15, 2007

Sponsor

Groupe Francophone des Myelodysplasies

1. Study Identification

Unique Protocol Identification Number

NCT00443339

Brief Title

Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

Official Title

A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Groupe Francophone des Myelodysplasies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 twice weekly for an additional 12 weeks in non responders. Response will be evaluated at 12 weeks. Patients with major or minor erythroid response (HI-E major or minor according to IWG 2000 criteria) will be continued on Aranesp. In non-responders, an additional 12 weeks of Aranesp at the same dosing, combined to Filgrastim (300 ug twice weekly, then adjusted to maintain WBC between 5000 and 10000/mm3) will be proposed. In case of response, the treatment will be continued for a total duration of 24 months. If Hb level reaches levels > 13 g/dl at any time, Aranesp should be discontinued until Hb levels are less than 12 g/dl. Aranesp should then be resumed at 500 µg/injection every 3 weeks. Intervals between injections should be further increased by one week every time they lead to Hb levels > 13 g/dl. The purpose of this dose adjustment is to reach the Aranesp schedule allowing a maintenance Hb level between 11 and 12 g/dl.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndromes with IPSS Low or Int-1, Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

99 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Darbepoetin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Tolerability and safety of darbepoetin alpha

Title

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

Title

Overall survival

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charikleia KELAIDI, MD

Phone

0033148957051

charikleia .kelaidi@avc.aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Fatima-Zohra HAMZA, RCA

Phone

0033148955890

fatima.hamza@avc.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charikleia KELAIDI, MD

Organizational Affiliation

Groupe Francophone des Myelodysplasies

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU d'Amiens

City

Amiens

ZIP/Postal Code

800054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ghandi DAMAJ, MD

Phone

0033322455915

damaj.Ghandi@chu-amiens.fr

Facility Name

CHU d'Angers

City

Angers

ZIP/Postal Code

43033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathilde HUNAULT-BERGER, Doctors

Phone

0033241354475

MaHunault@chu-angers.fr

Facility Name

CHU d'Avignon

City

Avignon

ZIP/Postal Code

84000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bohrane SLAMA, Doctor

Phone

0033432753120

bslama@chu-avignon.fr

Facility Name

CH de la Cote Basque

City

Bayonne

ZIP/Postal Code

64 100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Bauduer, MD

Phone

33 5 59 44 38 33

fbauduer001@chicb.com

Facility Name

CHU de Brest - Hopital Morvan

City

Brest

ZIP/Postal Code

29 609

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Berthou, MD

Phone

33 2 98 22 35 04

ChristianBerthou@wanadoo.fr

Facility Name

CHU de Caen

City

Caen

ZIP/Postal Code

14033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane CHEZE, MD

Phone

0033231272360

cheze-s@chu-caen.fr

First Name & Middle Initial & Last Name & Degree

CHEZE, MD

Facility Name

Hopital Percy

City

Clamart

ZIP/Postal Code

92140

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry DE REVEL, Profesor

Phone

0033141466301

hematologie-percy@wanadoo.fr

Facility Name

Hopital Henri Mondor

City

Créteil

ZIP/Postal Code

94010

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michel TULLIEZ, Profesor

Phone

003314982880

michel.tulliez@hmn.aphp.fr

Facility Name

CHU de Dijon

City

Dijon

ZIP/Postal Code

21034

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denis CAILLOT

Phone

0033380293645

First Name & Middle Initial & Last Name & Degree

BERGER, MD

First Name & Middle Initial & Last Name & Degree

BASTIE, MD

First Name & Middle Initial & Last Name & Degree

CASANOVAS, MD

First Name & Middle Initial & Last Name & Degree

SOLARY, Professor

Facility Name

CHU Albert Michallon

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Yves CAHN, Professor

Phone

0033476769445

JYCahn@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

CAHN, Professor

Facility Name

CHRU Hurriez

City

Lille

ZIP/Postal Code

59057

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno QUESNEL, Profesor

Phone

0033320446640

b-quesnel@chru.fr

First Name & Middle Initial & Last Name & Degree

QUESNEL, Professor

Facility Name

CHRU Limoges

City

Limoges

ZIP/Postal Code

87046

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominique BOURDESSOULE

Phone

0033555056642

bourdessoule@unilim.fr

First Name & Middle Initial & Last Name & Degree

Marie-Pierre CHAURY, Doctor

Facility Name

Hopital Edouard Herriot

City

Lyon

ZIP/Postal Code

69437

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Youcef CHELGHOUM, MD

Phone

0033472117324

youcef-chelghoum@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

MICHALLET, Professor

First Name & Middle Initial & Last Name & Degree

TRONCY, MD

First Name & Middle Initial & Last Name & Degree

CHELGHOUM, MD

Facility Name

Hopital Paoli Calmette

City

Marseille

ZIP/Postal Code

13273

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert VEY, MD

Phone

0033431223695

veyn@marseille.fnclcc.fr

First Name & Middle Initial & Last Name & Degree

VEY, MD

First Name & Middle Initial & Last Name & Degree

CHARBONNIER, MD

First Name & Middle Initial & Last Name & Degree

GASTAUT, Professor

First Name & Middle Initial & Last Name & Degree

BOUABDALLAH, MD

First Name & Middle Initial & Last Name & Degree

REY, MD

First Name & Middle Initial & Last Name & Degree

STOPPA, MD

Facility Name

Hopital Hotel Dieu

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Luc HAROUSSEAU

Phone

0033240083271

jean-luc.harousseau@univ-nantes.fr

First Name & Middle Initial & Last Name & Degree

HAROUSSEAU, Professor

Facility Name

CHU Archet

City

Nice

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence LEGROS, DOCTOR

Phone

0033492035844

legros@nice.fr

Facility Name

Hopital Hotel Dieu

City

Paris

ZIP/Postal Code

75181

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne VEKOFF, MD

Phone

00033142348586

anne.vekoff@htd.aphp.fr

Facility Name

Hopital Hotel Dieu

City

Paris

ZIP/Postal Code

75181

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole CASADEVALL, Profesor

Phone

0033142348266

nicole.casadavall@htd.aphp.fr

First Name & Middle Initial & Last Name & Degree

Zora MARJANOVIC, Doctor

First Name & Middle Initial & Last Name & Degree

Anne VEKHOFF, Doctor

Facility Name

Hopital St Louis

City

Paris

ZIP/Postal Code

75475

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herve DOMBRET, Profesor

Phone

0033142499643

herve.dombret@sls.aphp.fr

Facility Name

Hopital Saint Antoine

City

Paris

ZIP/Postal Code

75571

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francoise ISNARD, MD

Phone

00033149282622

francoise.isnard@sat.aphp.fr

First Name & Middle Initial & Last Name & Degree

ISNARD, MD

First Name & Middle Initial & Last Name & Degree

FOUILLARD, MD

First Name & Middle Initial & Last Name & Degree

LEMONNIER, MD

First Name & Middle Initial & Last Name & Degree

LAPORTE, MD

First Name & Middle Initial & Last Name & Degree

GARDERET, MD

First Name & Middle Initial & Last Name & Degree

COPPO, MD

First Name & Middle Initial & Last Name & Degree

GORIN, Professor

First Name & Middle Initial & Last Name & Degree

RAFFOUX, MD

Facility Name

Hopital Cochin

City

Paris

ZIP/Postal Code

75679

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francois DREYFUS, Professor

Phone

003358412120

francois.dreyfus@cch.aphp.fr

First Name & Middle Initial & Last Name & Degree

DREYFUS, Professor

Facility Name

Hopital Jean-Bernard

City

Poitiers

ZIP/Postal Code

86021

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francois GUILHOT, Professor

Phone

0033549444201

f.guilhot@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

GUILHOT, Profesor

First Name & Middle Initial & Last Name & Degree

ROY, MD

Facility Name

CHU Robert Debre

City

Reims

ZIP/Postal Code

51092

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chantal HIMBERLIN, Doctor

Phone

0033326783644

chimberli@chu-reims.fr

First Name & Middle Initial & Last Name & Degree

Brigitte KOLB, Doctor

Facility Name

CHU Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine ESCOFFRE-BARBE

Phone

0033299284291

martine.escoffre-barbe@chu-rennes.fr

First Name & Middle Initial & Last Name & Degree

ESCOFFRE-BARBE, MD

First Name & Middle Initial & Last Name & Degree

DAURIAC, MD

First Name & Middle Initial & Last Name & Degree

BERNARD, MD

First Name & Middle Initial & Last Name & Degree

LAMY, MD

First Name & Middle Initial & Last Name & Degree

NIMUBONA, MD

Facility Name

Hopital Henri Becquerel

City

Rouen

ZIP/Postal Code

76038

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aspasia STAMATOULLAS, Doctor

Phone

0033232082288

astamatoullas@rouen.fnclcc.fr

Facility Name

Hopital Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shanti AME, MD

Phone

0033388127680

shanti.ame@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

AME, MD

Facility Name

Hopital Purpan

City

Toulouse

ZIP/Postal Code

31031

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guy LAURENT, Professor

Phone

0033561772078

laurent.g@chu-toulouse.fr

First Name & Middle Initial & Last Name & Degree

LAURENT, Professor

Facility Name

Hopital Bretonneau

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe COLOMBAT, Profesor

Phone

0033247473712

colombat@med.univ-tours.fr

Facility Name

CHU Nancy-Brabois

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnes Guerci-Bresler, MD

Phone

33 83 15 32 82 / 81

a.guerci@chu-nancy.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

23358617

Citation

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. Erratum In: Ann Hematol. 2013 May;92(5):633. Lambert, Christine [corrected to Lamberto, C].

Results Reference

derived

Learn more about this trial

Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

We'll reach out to this number within 24 hrs

Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial