search
Back to results

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

Primary Purpose

Myelodysplastic Syndrome

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic syndrome

Eligibility Criteria

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

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

Sites / Locations

  • Hospital Central de Asturias
  • Hospital de Cruces
  • Hospital Virgen del Puerto
  • Hospital General Universitario de Alicante
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Vall D´Hebron
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Duran i Reynals
  • Hospital General Yagüe
  • Hospital Universitario Puerta del Mar
  • Complejo Hospitalario Universitario Juan Canalejo
  • Hospital Ramón y Cajal
  • Hospital Universitario Doce de Octubre
  • Hospital Universitario de Salamanca
  • Hospital Universitario La Fé
  • Hospital Arnau de Vilanova

Outcomes

Primary Outcome Measures

Proportion of patients achieving an erythroid response during the 24-week treatment period.

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2009
Last Updated
January 12, 2010
Sponsor
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
search

1. Study Identification

Unique Protocol Identification Number
NCT01039350
Brief Title
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
Official Title
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
It was stopped due to a lack of recruitment after 48 patients included
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Darbepoetin alfa will be initiated at a weekly (QW) subcutaneous dose of 300 mcg over 8 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients achieving an erythroid response during the 24-week treatment period.
Time Frame
weeks 8; 12; 16 and 24
Secondary Outcome Measure Information:
Title
Time to erythroid response and time it is maintained.
Time Frame
week 24
Title
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
Title
Proportion of patients receiving RBC transfusions (more than 1 unit) from week 5 to 24, inclusive
Time Frame
weeks 8; 12; 16 and 24
Title
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
Title
Number of morphological and cytogenetic disorders at baseline and end of treatment
Time Frame
week 24
Title
Incidence of adverse events and serious adverse events
Time Frame
weeks 8; 12; 16 and 24
Title
Proportion of patients with haemoglobin values over 12 g/dL at any time during the study
Time Frame
weeks 8; 12; 16 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Villegas, MD
Organizational Affiliation
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Virgen del Puerto
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall D´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Yagüe
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Complejo Hospitalario Universitario Juan Canalejo
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario La Fé
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
6952920
Citation
Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.
Results Reference
background
PubMed Identifier
11698274
Citation
Nosslinger T, Reisner R, Koller E, Gruner H, Tuchler H, Nowotny H, Pittermann E, Pfeilstocker M. Myelodysplastic syndromes, from French-American-British to World Health Organization: comparison of classifications on 431 unselected patients from a single institution. Blood. 2001 Nov 15;98(10):2935-41. doi: 10.1182/blood.v98.10.2935.
Results Reference
background
PubMed Identifier
9058730
Citation
Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88. Erratum In: Blood 1998 Feb 1;91(3):1100.
Results Reference
background
PubMed Identifier
11276043
Citation
Littlewood TJ. Erythropoietin for the treatment of anemia associated with hematological malignancy. Hematol Oncol. 2001 Mar;19(1):19-30. doi: 10.1002/hon.663.
Results Reference
background
PubMed Identifier
12160363
Citation
Molldrem JJ, Leifer E, Bahceci E, Saunthararajah Y, Rivera M, Dunbar C, Liu J, Nakamura R, Young NS, Barrett AJ. Antithymocyte globulin for treatment of the bone marrow failure associated with myelodysplastic syndromes. Ann Intern Med. 2002 Aug 6;137(3):156-63. doi: 10.7326/0003-4819-137-3-200208060-00007.
Results Reference
background
PubMed Identifier
11493439
Citation
Raza A, Meyer P, Dutt D, Zorat F, Lisak L, Nascimben F, du Randt M, Kaspar C, Goldberg C, Loew J, Dar S, Gezer S, Venugopal P, Zeldis J. Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. Blood. 2001 Aug 15;98(4):958-65. doi: 10.1182/blood.v98.4.958.
Results Reference
background
PubMed Identifier
10233377
Citation
Stasi R, Pagano A, Terzoli E, Amadori S. Recombinant human granulocyte-macrophage colony-stimulating factor plus erythropoietin for the treatment of cytopenias in patients with myelodysplastic syndromes. Br J Haematol. 1999 Apr;105(1):141-8.
Results Reference
background
PubMed Identifier
8639764
Citation
Negrin RS, Stein R, Doherty K, Cornwell J, Vardiman J, Krantz S, Greenberg PL. Maintenance treatment of the anemia of myelodysplastic syndromes with recombinant human granulocyte colony-stimulating factor and erythropoietin: evidence for in vivo synergy. Blood. 1996 May 15;87(10):4076-81.
Results Reference
background
PubMed Identifier
1483451
Citation
Koury MJ, Bondurant MC. The molecular mechanism of erythropoietin action. Eur J Biochem. 1992 Dec 15;210(3):649-63. doi: 10.1111/j.1432-1033.1992.tb17466.x. No abstract available.
Results Reference
background
PubMed Identifier
12437640
Citation
Rigolin GM, Porta MD, Bigoni R, Cavazzini F, Ciccone M, Bardi A, Cuneo A, Castoldi G. rHuEpo administration in patients with low-risk myelodysplastic syndromes: evaluation of erythroid precursors' response by fluorescence in situ hybridization on May-Grunwald-Giemsa-stained bone marrow samples. Br J Haematol. 2002 Dec;119(3):652-9. doi: 10.1046/j.1365-2141.2002.03867.x.
Results Reference
background
PubMed Identifier
9639501
Citation
Hellstrom-Lindberg E, Ahlgren T, Beguin Y, Carlsson M, Carneskog J, Dahl IM, Dybedal I, Grimfors G, Kanter-Lewensohn L, Linder O, Luthman M, Lofvenberg E, Nilsson-Ehle H, Samuelsson J, Tangen JM, Winqvist I, Oberg G, Osterborg A, Ost A. Treatment of anemia in myelodysplastic syndromes with granulocyte colony-stimulating factor plus erythropoietin: results from a randomized phase II study and long-term follow-up of 71 patients. Blood. 1998 Jul 1;92(1):68-75.
Results Reference
background
PubMed Identifier
10586205
Citation
Remacha AF, Arrizabalaga B, Villegas A, Manteiga R, Calvo T, Julia A, Fernandez Fuertes I, Gonzalez FA, Font L, Junca J, del Arco A, Malcorra JJ, Equiza EP, de Mendiguren BP, Romero M. Erythropoietin plus granulocyte colony-stimulating factor in the treatment of myelodysplastic syndromes. Identification of a subgroup of responders. The Spanish Erythropathology Group. Haematologica. 1999 Dec;84(12):1058-64.
Results Reference
background
PubMed Identifier
10666187
Citation
Thompson JA, Gilliland DG, Prchal JT, Bennett JM, Larholt K, Nelson RA, Rose EH, Dugan MH. Effect of recombinant human erythropoietin combined with granulocyte/ macrophage colony-stimulating factor in the treatment of patients with myelodysplastic syndrome. GM/EPO MDS Study Group. Blood. 2000 Feb 15;95(4):1175-9.
Results Reference
background
PubMed Identifier
11137555
Citation
Hast R, Wallvik J, Folin A, Bernell P, Stenke L. Long-term follow-up of 18 patients with myelodysplastic syndromes responding to recombinant erythropoietin treatment. Leuk Res. 2001 Jan;25(1):13-18. doi: 10.1016/s0145-2126(00)00073-4.
Results Reference
background
PubMed Identifier
9886322
Citation
Italian Cooperative Study Group for rHuEpo in Myelodysplastic Syndromes; Ferrini PR, Grossi A, Vannucchi AM, Barosi G, Guarnone R, Piva N, Musto P, Balleari E. A randomized double-blind placebo-controlled study with subcutaneous recombinant human erythropoietin in patients with low-risk myelodysplastic syndromes. Br J Haematol. 1998 Dec;103(4):1070-4. doi: 10.1046/j.1365-2141.1998.01085.x.
Results Reference
background
PubMed Identifier
12100145
Citation
Terpos E, Mougiou A, Kouraklis A, Chatzivassili A, Michalis E, Giannakoulas N, Manioudaki E, Lazaridou A, Bakaloudi V, Protopappa M, Liapi D, Grouzi E, Parharidou A, Symeonidis A, Kokkini G, Laoutaris NP, Vaipoulos G, Anagnostopoulos NI, Christakis JI, Meletis J, Bourantas KL, Zoumbos NC, Yataganas X, Viniou NA; Greek MDS Study Group. Prolonged administration of erythropoietin increases erythroid response rate in myelodysplastic syndromes: a phase II trial in 281 patients. Br J Haematol. 2002 Jul;118(1):174-80. doi: 10.1046/j.1365-2141.2002.03583.x.
Results Reference
background
PubMed Identifier
7833279
Citation
Hellstrom-Lindberg E. Efficacy of erythropoietin in the myelodysplastic syndromes: a meta-analysis of 205 patients from 17 studies. Br J Haematol. 1995 Jan;89(1):67-71. doi: 10.1111/j.1365-2141.1995.tb08909.x.
Results Reference
background
PubMed Identifier
10848827
Citation
Mantovani L, Lentini G, Hentschel B, Wickramanayake PD, Loeffler M, Diehl V, Tesch H. Treatment of anaemia in myelodysplastic syndromes with prolonged administration of recombinant human granulocyte colony-stimulating factor and erythropoietin. Br J Haematol. 2000 May;109(2):367-75. doi: 10.1046/j.1365-2141.2000.02016.x.
Results Reference
background
PubMed Identifier
15054036
Citation
Casadevall N, Durieux P, Dubois S, Hemery F, Lepage E, Quarre MC, Damaj G, Giraudier S, Guerci A, Laurent G, Dombret H, Chomienne C, Ribrag V, Stamatoullas A, Marie JP, Vekhoff A, Maloisel F, Navarro R, Dreyfus F, Fenaux P. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood. 2004 Jul 15;104(2):321-7. doi: 10.1182/blood-2003-07-2252. Epub 2004 Mar 30.
Results Reference
background
PubMed Identifier
11090046
Citation
Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4.
Results Reference
background
PubMed Identifier
12648074
Citation
Hellstrom-Lindberg E, Gulbrandsen N, Lindberg G, Ahlgren T, Dahl IM, Dybedal I, Grimfors G, Hesse-Sundin E, Hjorth M, Kanter-Lewensohn L, Linder O, Luthman M, Lofvenberg E, Oberg G, Porwit-MacDonald A, Radlund A, Samuelsson J, Tangen JM, Winquist I, Wisloff F; Scandinavian MDS Group. A validated decision model for treating the anaemia of myelodysplastic syndromes with erythropoietin + granulocyte colony-stimulating factor: significant effects on quality of life. Br J Haematol. 2003 Mar;120(6):1037-46. doi: 10.1046/j.1365-2141.2003.04153.x.
Results Reference
background
PubMed Identifier
11308268
Citation
Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):3-10. doi: 10.1054/bjoc.2001.1746.
Results Reference
background
PubMed Identifier
11953669
Citation
Smith R. Applications of darbepoietin-alpha, a novel erythropoiesis-stimulating protein, in oncology. Curr Opin Hematol. 2002 May;9(3):228-33. doi: 10.1097/00062752-200205000-00009.
Results Reference
background
PubMed Identifier
10541299
Citation
Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Browne J, Egrie J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol. 1999 Nov;10(11):2392-5. doi: 10.1681/ASN.V10112392.
Results Reference
background
PubMed Identifier
12957457
Citation
Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.
Results Reference
background
PubMed Identifier
9375752
Citation
Hellstrom-Lindberg E, Negrin R, Stein R, Krantz S, Lindberg G, Vardiman J, Ost A, Greenberg P. Erythroid response to treatment with G-CSF plus erythropoietin for the anaemia of patients with myelodysplastic syndromes: proposal for a predictive model. Br J Haematol. 1997 Nov;99(2):344-51. doi: 10.1046/j.1365-2141.1997.4013211.x.
Results Reference
background
PubMed Identifier
12177793
Citation
Glaspy JA, Jadeja JS, Justice G, Kessler J, Richards D, Schwartzberg L, Tchekmedyian NS, Armstrong S, O'Byrne J, Rossi G, Colowick AB. Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br J Cancer. 2002 Jul 29;87(3):268-76. doi: 10.1038/sj.bjc.6600465.
Results Reference
background
PubMed Identifier
15638854
Citation
Musto P, Lanza F, Balleari E, Grossi A, Falcone A, Sanpaolo G, Bodenizza C, Scalzulli PR, La Sala A, Campioni D, Ghio R, Cascavilla N, Carella AM. Darbepoetin alpha for the treatment of anaemia in low-intermediate risk myelodysplastic syndromes. Br J Haematol. 2005 Jan;128(2):204-9. doi: 10.1111/j.1365-2141.2004.05288.x.
Results Reference
background
PubMed Identifier
16681638
Citation
Mannone L, Gardin C, Quarre MC, Bernard JF, Vassilieff D, Ades L, Park S, Vaultier S, Hamza F, Beyne-rauzy MO, Cheze S, Giraudier S, Agape P, Legros L, Voillat L, Dreyfus F, Fenaux P; Groupe Francais des Myelodysplasies. High-dose darbepoetin alpha in the treatment of anaemia of lower risk myelodysplastic syndrome results of a phase II study. Br J Haematol. 2006 Jun;133(5):513-9. doi: 10.1111/j.1365-2141.2006.06070.x.
Results Reference
background
PubMed Identifier
12189224
Citation
Vansteenkiste J, Pirker R, Massuti B, Barata F, Font A, Fiegl M, Siena S, Gateley J, Tomita D, Colowick AB, Musil J; Aranesp 980297 Study Group. Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst. 2002 Aug 21;94(16):1211-20. doi: 10.1093/jnci/94.16.1211.
Results Reference
background
PubMed Identifier
12877666
Citation
Hedenus M, Adriansson M, San Miguel J, Kramer MH, Schipperus MR, Juvonen E, Taylor K, Belch A, Altes A, Martinelli G, Watson D, Matcham J, Rossi G, Littlewood TJ; Darbepoetin Alfa 20000161 Study Group. Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol. 2003 Aug;122(3):394-403. doi: 10.1046/j.1365-2141.2003.04448.x.
Results Reference
background
PubMed Identifier
12799626
Citation
Smith RE Jr, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J. A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. Br J Cancer. 2003 Jun 16;88(12):1851-8. doi: 10.1038/sj.bjc.6600994.
Results Reference
background
Citation
Hellstrom-Lindberg E. Growth factor treatment for the anemia of MDS: mechanisms and efficacy. Educational Programme at the 8th Congress of the European Haematology Association (EHA), June 2003
Results Reference
background
Citation
Verhoef GEG, Boogaerts MA. RHuEPO in the treatment of the myelodysplastic syndromes. In: Smyth JF, Boogaerts MA, Ehmer BR-M (eds): rHuEPO in cancer supportive treatment. Marcel Dekker, New York 1996;pp.13-34.
Results Reference
background
Citation
Heatherington AC, Schuller J, Kotasek D, et al. The pharmacokinetics of darbepoetin alfa and changes in endogenous erythropoietin in patients with nonmyeloid malignancies receiving or not receiving chemotherapy. European Breast Cancer Conference (EBCC) 2002. Abstract.
Results Reference
background
Citation
Glaspy J, Appelbaum S, Henry D et al. Effects of darbepoetin alfa (Aranesp®) timing with chemotherapy administration: a randomized study. SIOG 2003. Poster.
Results Reference
background
Citation
WHO Classification Tumours of Haematopoietic and Lymphoid Tissues. IARC Press, Lyon 2001
Results Reference
background
PubMed Identifier
21381892
Citation
Villegas A, Arrizabalaga B, Fernandez-Lago C, Castro M, Mayans JR, Gonzalez-Porras JR, Duarte RF, Remacha AF, Luno E, Gasquet JA. Darbepoetin alfa for anemia in patients with low or intermediate-1 risk myelodysplastic syndromes and positive predictive factors of response. Curr Med Res Opin. 2011 May;27(5):951-60. doi: 10.1185/03007995.2011.561834. Epub 2011 Mar 7.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs