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A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

16. oktober 2019 oppdatert av: Celgene

A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.

See study AZA PH GL 2003 CL 001 E for information about the extension to this study.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Comparison/Control Interventions offered the physician three options:

  • Best supportive care (BSC) alone,
  • Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
  • Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).

All three options included best supportive care. Neither the experimental group (azacitidine) nor any of the comparison/control options allowed use of erythropoietin.

Duration of Intervention: Patients will be treated until death, withdrawal, unacceptable toxicity or conclusion of the study.

Studietype

Intervensjonell

Registrering (Faktiske)

358

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Warratah, New South Wales, Australia, 2298
        • The Newcastle Mater Miseriecordiae Hospital
    • Queensland
      • Hersten, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Institute
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3181
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6847
        • The Royal Perth Hospital
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • First Clinical Base - Clinic of Hematology, MHAT - Pleven
      • Plovdiv, Bulgaria, 4004
        • III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
      • Plovdiv, Bulgaria, 4002
        • MHAT "St George" Clinic of Hematology, Plovdiv
      • Sofia, Bulgaria, 1756
        • National Centre of Hematology and Transfusiology, Sofia
      • Varna, Bulgaria, 9010
        • University Multiprofile Hospital for Active Treatment "Sveta Marina"
      • Varna, Bulgaria, 3010
        • Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 105299
        • Burdenko Central Military Clinical Hospital
      • Moscow, Den russiske føderasjonen, 115487
        • Blokhin Cancer Research Center
      • Moscow, Den russiske føderasjonen, 125167
        • Scientific Haematology Center, Moscow
      • St. Petersburg, Den russiske føderasjonen, 197089
        • Pavlov State Medical University
      • St. Petersburg, Den russiske føderasjonen, 197110
        • City Hospital #31
      • St. Petersburg, Den russiske føderasjonen, 193024
        • Institute of Haematology & Blood Transfusion
      • St. Petersburg, Den russiske føderasjonen, 197022
        • Pavlov State Medical University
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University Cancer Center
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, Forente stater, 10029-6574
        • Mount Sinai Medical Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
    • Oregon
      • Portland, Oregon, Forente stater, 97201
        • Oregon Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Western Pennsylvania Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Froedtert Memorial Lutheran Hospital
  • Frankrike
      • Angers, Frankrike, 49033
        • CHU d'Angers
      • Clichy, Frankrike, 92110
        • Hopital Beaujon
      • Lille, Frankrike, 59037
        • Che De Lille
      • Lyon, Frankrike, 69437
        • Hospital Edouard Herriot
      • Marseille, Frankrike, 13009
        • Institute Paoli Calmettes
      • Nantes, Frankrike, 44093
        • CHU de Nantes
      • Paris, Frankrike, 75679
        • Hopital Cochin
      • Paris, Frankrike, 75010
        • Hospital Saint Louis
      • Rouen, Frankrike, 76038
        • Centre Henri Becquerel
      • Toulouse, Frankrike, 31059
        • Chu Purpan
  • Hellas
      • Athens, Hellas, 11527
        • District General Hospital of Athens
      • Athens, Hellas, 11527
        • General Hospital of Chest Disease
      • Ioannina, Hellas, 45500
        • University General Hospital of Ioannina
      • Patra, Hellas, 26500
        • University General Hospital of Patra Rio
    • Athens
      • Haidari, Athens, Hellas, 12462
        • University Hospital-Attikon
    • Crete
      • Heraklio, Crete, Hellas, 71110
        • University General Hospital of Heraklio Voutes
  • Italia
      • Bologna, Italia, 40138
        • Policlinico S. Orsola-Malpighi
      • Firenze, Italia, 50139
        • Universita Di Firenze
      • Genova, Italia, I-16132
        • Ospedale San Martino
      • Milano, Italia, 20133
        • Instituto Nazionale Dei Tumori
      • Modena, Italia, 41100
        • Centro Oncologico Modenese
      • Roma, Italia, 00168
        • Policlinico Gemelli
      • Roma, Italia, 00144
        • Ospedale San Eugenio
      • Roma, Italia, 144
        • Instituto Nazionale Tumori "Regina Elena"
      • San Giovanni Rotondo, Italia, 71013
        • Ospedale Casa Sollievo Della Sofferenza - Irrc
      • Sassari, Italia, 7100
        • Università degli Studi di Sassari
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • VU University Medical Center Amsterdam
      • Nijmejen, Nederland
        • Univ Hospital St. Radboud
  • Polen
      • Gdansk, Polen, 80-952
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Lodz, Polen, 93-510
        • Wojewodzki Szpital Specjalistyczny
      • Lublin, Polen, 20081
        • Samodzielny Publiczny Szpital Kliniczny
      • Warszawa, Polen, 00-909
        • Wojskowy Instytut Medyczny
      • Warszawa, Polen, 02-097
        • Samodzelny Publiczny Centralny Szpital Kliniczny
      • Wroclaw, Polen, 50-367
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Spania
      • Barcelona, Spania, 08036
        • Hospital Clínic
      • Barcelona, Spania, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spania
        • Hospital Universitario Germans Trias i Pujol
      • Leon, Spania, 24071
        • Hospital de Leon
      • Madrid, Spania, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spania, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spania, 28046
        • Hospital La Paz, Madrid
      • Madrid, Spania, 28048
        • Hospital Clinico San Carlos
      • Palma de Mallorca, Spania, 07198
        • Hospital Son Llàtzer
      • Salamanca, Spania, 37007
        • Hospital Universitario Del Salamanca
      • Valencia, Spania, 46009
        • Hospital Universitario La Fe
  • Storbritannia
      • Bournemouth, Storbritannia, BH7 7DW
        • Royal Bournemouth General Hospital
      • London, Storbritannia, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, Storbritannia
        • Kings College Hospital NHS Trust
      • Manchester, Storbritannia, M20 4BX
        • Christie Hospital
      • Norwich, Storbritannia, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Oxford, Storbritannia, OX3 9DU
        • John Radcliffe Hospital
      • Truro, Storbritannia, TR1 3LJ
        • Royal Cornwall Hospital
  • Sverige
      • Goteborg, Sverige, S-413 45
        • Sahlgrenska University Hospital
      • Lund, Sverige, 22185
        • Lund Universtiy Hospital
      • Malmo, Sverige, S-205 02
        • University Hospital MAS
      • Stockholm, Sverige, 14186
        • Huddinge University Hospital
      • Uppsala, Sverige, S-751 85
        • Uppsala University Hospital
  • Tsjekkia
      • Olomouc, Tsjekkia, 775 20
        • Fakultni nemocnice Olomouc
      • Praha, Tsjekkia, 2 128 08
        • Všeobecná fakultní nemocnice
      • Praha, Tsjekkia, 2 128 20
        • Uslav Hematologie a Krevni Transfuze
    • Brno
      • Jihlavska, Brno, Tsjekkia, 639 00
        • Fakultni nemocnice Brno
    • Hradec Kralove
      • Sokolska, Hradec Kralove, Tsjekkia, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Tyskland
      • Bonn, Tyskland, 53105
        • Universitätsklinikum Bonn
      • Chemnitz, Tyskland, 9113
        • Klinikum Chemnitz gGmbH
      • Dresden, Tyskland, 1307
        • Universitätsklinikum Carl Gustav Carus
      • Duisburg, Tyskland, 47166
        • St Johannes Hospital
      • Dusseldorf, Tyskland, 40225
        • Heinrich-Heine University Düsseldorf
      • Essen, Tyskland, 45147
        • University Essen
      • Gottingen, Tyskland, 37075
        • Gerorg-August-Universitat Gottingen
      • Hamburg, Tyskland, D-20099
        • Allgemeines Krankenhaus St. Georg
      • Hamburg, Tyskland, D-20246
        • Universitatsklinikum Hambur-Eppendorf
      • Kiel, Tyskland, D-24116
        • Universitatsklinikum Kiel II
      • Ulm, Tyskland, 89070
        • Universitatsklinikum Ulm
    • Berlin
      • Hindenburgdamm, Berlin, Tyskland, D-12203
        • Universitatsklinikum Benjamin Franklin
  • Ungarn
      • Budapest, Ungarn, 1135
        • Orszagos Gyogyintezeti Kozpont
      • Pecs, Ungarn, 7624
        • University of Pecs, 1st Dept of Internal Medicine
      • Szeged, Ungarn, 6701
        • University of Szeged, 2nd Department of Internal Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Have a diagnosis of refractory anemia with excess blasts or refractory anemia with excess blasts in transformation according to the French-American-British classification system for myelodysplastic syndromes (MDS) and a relatively high risk of acute myeloid leukemia (AML) transformation, with an International Prognostic Scoring System score of INT-2 or High.
  • Be 18 years of age or older
  • Have a life expectancy of at least 3 months
  • Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission
  • Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normal range for the laboratory
  • Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 times the upper limit of normal (unless these are considered to be related to transfusion-induced secondary hemosiderosis)
  • Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal

Exclusion Criteria:

  • Secondary myelodysplastic syndromes (MDS)
  • Prior treatment with azacitidine;
  • Prior history of acute myeloid leukemia (AML);
  • Malignant disease diagnosed within prior 12 months;
  • Metastatic disease;
  • Hepatic tumors;
  • Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12 months;
  • Prior transplantation or cytotoxic therapy to treat MDS;
  • Serious medical illness likely to limit survival to 12 months or less;
  • Treatment with erythropoietin or myeloid growth factors during prior 21 days or androgenic hormones during prior 13 days;
  • Active HIV, viral hepatitis type B or C;
  • Treatment with investigational drugs during prior 30 days;
  • Within the 28-day screening period, documented red cell folate deficiency, as evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Azacitidine
Study Drug plus best supportive care. Treatment with erythropoietin was not permitted
Legemiddel: Azacitidine
Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
Andre navn:
  • AZA
Aktiv komparator: Conventional Care
Physician choice of low dose cytarabine (plus best supportive care), standard chemotherapy (plus best supportive care) or best supportive care (only). Treatment with erythropoietin was not permitted
Annen: Physician Choice

Physician Choice was one of three options:

  • Best supportive care (BSC) alone,
  • Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
  • Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).

All three options included best supportive care

Andre navn:
  • cytarabin
  • antracyklin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kaplan-Meier Estimates for Median Time to Death From Any Cause
Tidsramme: Day 1 (randomization) to 42 months
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
Day 1 (randomization) to 42 months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause
Tidsramme: Day 1 (randomization) to 42 months

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.

Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.
Day 1 (randomization) to 42 months
Number of Participants Who Died
Tidsramme: 42 months
Count of participants who died during the study
42 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
Tidsramme: Day 1 (randomization) to 42 months
The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.
Day 1 (randomization) to 42 months
Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)
Tidsramme: Day 1 (randomization) to 42 months
The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.
Day 1 (randomization) to 42 months
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Tidsramme: Day 1 (randomization) to 42 months
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Tidsramme: Day 1 (randomization) to 42 months
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Tidsramme: Day 1 (randomization) to 42 months
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Tidsramme: Day 1 (randomization) to 42 months
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)
Tidsramme: Day 1 to 42 months

Investigator determined responses followed IWG criteria for

  • complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia
  • partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment
  • stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months.
Day 1 to 42 months
Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee
Tidsramme: Day 1 to 42 months

IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.

Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.

Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.

Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L.
Day 1 to 42 months
Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause
Tidsramme: Day 1 (randomization) to 42 months
The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.
Day 1 (randomization) to 42 months
Duration of Any Hematologic Improvement
Tidsramme: Day 1 (randomization) to 42 months
The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.
Day 1 (randomization) to 42 months
Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals
Tidsramme: Day 1 (randomization) to 42 months
The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.
Day 1 (randomization) to 42 months
Number of Participants in Different Categories of Adverse Experiences During Core Study Period
Tidsramme: Day 1 (randomization) to 42 months
Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.
Day 1 (randomization) to 42 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Celgene

Etterforskere

  • Studieleder: CL Beach, Celgene Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2003

Primær fullføring (Faktiske)

1. juli 2007

Studiet fullført (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først innsendt

31. oktober 2003

Først innsendt som oppfylte QC-kriteriene

4. november 2003

Først lagt ut (Anslag)

5. november 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AZA PH GL 2003 CL001

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Myelodysplastiske syndromer

Kliniske studier på Azacitidine

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