- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01381809
An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes
14 mars 2016 uppdaterad av: Janssen-Cilag International NV
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes
The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS).
The safety of epoetin alfa will also be evaluated.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a randomized (the treatment you receive will be assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled (comparison with patients that receive treatment without active ingredient), multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria.
This study includes a 3-week prerandomization phase, a 24-week treatment phase and a 24-week treatment extension phase.
All patients enrolled in the study will complete an end-of-study visit 4 weeks after the last dose of study drug (Week 28 or Week 52), or 4 weeks after early withdrawal (unless the reason for early withdrawal is withdrawal of consent).
Between 125 and 159 patients will be enrolled in the treatment phase of the study.
During the screening phase, which will take place within 2 weeks before starting study drug, the study doctor will do tests to see if the patient is suitable for this study.
Patients meeting entry criteria for the study will then be randomly assigned to one of the 2 treatment groups.
This means that each patient who is allowed to join the study is put into a group by chance, like flipping a coin.
Group 1 patients will receive epoetin alfa 450 or increased up to 1050 International Units (IU) per kg body weight administered by subcutaneous injection (injection beneath the skin) using pre-filled syringes.
Injections will be done once every week at a weight-based dose regimen (the total weekly dose received will depend on your weight) with a possible total maximum dose of 40,000 IU once every week for the first 8 weeks of the treatment phase and 80,000 IU once every week at any other time during the study.
Group 2 patients will receive a matching volume of placebo administered once every week by subcutaneous injection.
The chance that the patient will get epoetin alfa is 2 to 1. Doses of study drug will be withheld, decreased, or increased on the basis of erythroid response, weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines.
Patients will see the study doctor every 4 weeks for a period of 24 weeks.
At each visit the patient will undergo a full hematologic evaluation, serum chemistry evaluation, measurement of blood pressure and pulse rate, recording of blood product transfusions and transfusion complications, adverse events, concomitant therapies and an evaluation for disease progression.
The patient's Erythroid response will be assessed at Week 8 and every 4 weeks thereafter, until Week 24.
Blinded study treatment will be administered to all patients at Week 24.
However, at the end of the treatment phase (after the Week 24 response assessment), only responders will enter the double-blind treatment extension phase to measure the duration of response.
Patients will continue to receive the same treatment, in the same blinded fashion, and at the same dose as received at Week 24, and will return to the study center every 4 weeks, until Week 48, for assessment of the Erythroid response and the evaluations as described above.
For all non-responders at Week 24 the treatment code will be broken after Week 28 assessments.
For responders at Week 48, the treatment code will be broken after the Week 48 visit, following completion of the response assessment.
The treatment code will not be broken for subjects who discontinue study treatment before Week 24, irrespective of whether they are responders or nonresponders.
For these subjects, the blind will not be broken until all subjects have completed the study and the database is final.
Once the patient stops receiving doses of study drug, he/she will be asked to see the study doctor for the safety follow-up visit, which is scheduled 4 weeks after the last dose of study drug.
Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events.
An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression.
The total duration of study participation will be for about 30 or 54 weeks.
Studietyp
Interventionell
Inskrivning (Faktisk)
130
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Plovdiv, Bulgarien
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Sofia, Bulgarien
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Varna, Bulgarien
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Amiens, Frankrike
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Angers Cedex 9, Frankrike
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Bobigny, Frankrike
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Colmar, Frankrike
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Paris Cedex 10, Frankrike
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Pessac Cedex, Frankrike
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Pierre Benite Cedex, Frankrike
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Saint Priest En Jarez, Frankrike
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Tours Cedex 9, Frankrike
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Vandoeuvre Les Nancy, Frankrike
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Athens, Grekland
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Goudi-Athens, Grekland
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Larisa, Grekland
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Patra, Grekland
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Thessalonikis, Grekland
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Ekaterinburg, Ryska Federationen
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St. Petersburg, Ryska Federationen
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Berlin, Tyskland
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Dresden, Tyskland
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Duisburg, Tyskland
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Düsseldorf, Tyskland
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Dÿsseldorf, Tyskland
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München, Tyskland
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Oldenburg, Tyskland
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Würzburg, Tyskland
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening
- Documentation of an International Prognostic Scoring System score indicating Low- or Intermediate-1-risk disease within 12 weeks prior to screening
- Hemoglobin concentration at screening and baseline (before the first dose of study drug) of 10.0 g/dL or less
- Screening serum erythropoietin concentration of less than 500 mU/mL
- Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell units over the last 8 weeks before randomization
Exclusion Criteria:
- Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding)
- Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation therapy/exposure)
- History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ of the cervix or breast curatively treated
- Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization
- Prior use of approved or experimental agents for the treatment of MDS
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Epoetin alfa
Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks
|
type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks
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Placebo-jämförare: No treatment
Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks
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form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Erythroid response
Tidsram: at week 24
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at week 24
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Maintenance of Erythroid response
Tidsram: every 4 weeks from week 24 to week 48
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every 4 weeks from week 24 to week 48
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Duration of response
Tidsram: every 4 weeks after week 24
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every 4 weeks after week 24
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Time to first Red Blood Cell transfusion
Tidsram: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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Transfusion-free intervals
Tidsram: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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Number of Red Blood Cell units transfused
Tidsram: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
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Quality of life as measured by Functional Assessment of Cancer Therapy-Anemia/Fatigue (FACT-An) questionnaire
Tidsram: at baseline, week 24 and week 48
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at baseline, week 24 and week 48
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Quality of life as measured by EuroQol 5-dimension (EQ-5D) questionnaire
Tidsram: at baseline, week 24 and week 48
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at baseline, week 24 and week 48
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Drug consumption
Tidsram: every 4 weeks from baseline to week 48
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every 4 weeks from baseline to week 48
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Duration of hospitalization
Tidsram: every 4 weeks from baseline to week 48
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every 4 weeks from baseline to week 48
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Number and duration of medical care encounters
Tidsram: every 4 weeks from baseline to week 48
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every 4 weeks from baseline to week 48
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2011
Primärt slutförande (Faktisk)
1 januari 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
23 juni 2011
Först inskickad som uppfyllde QC-kriterierna
23 juni 2011
Första postat (Uppskatta)
27 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 mars 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR018367
- EPOANE3021 (Annan identifierare: Janssen-Cilag International NV)
- 2010-022884-36 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Myelodysplastiska syndrom
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M.D. Anderson Cancer CenterHar inte rekryterat ännuMyeloproliferativ neoplasma | Myelodysplastisk neoplasma | Pathway Mutant Myelodysplastic SyndromeFörenta staterna
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M.D. Anderson Cancer CenterAktiv, inte rekryterandeÅterkommande akut myeloid leukemi | Återkommande kronisk myelomonocytisk leukemi | Refraktär Akut Myeloid Leukemi | Refraktär kronisk myelomonocytisk leukemi | Återkommande myelodysplastisk/myeloproliferativ neoplasm | Refractory Myelodysplastic/Myeloproliferative NeoplasmFörenta staterna
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Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.AvslutadTidigare behandlat myelodysplastiskt syndrom | Myelodysplastiskt syndrom | Terapierelaterat myelodysplastiskt syndrom | Sekundärt myelodysplastiskt syndrom | Refraktärt högrisk myelodysplastiskt syndromFörenta staterna
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
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National Cancer Institute (NCI)AvslutadTidigare behandlade myelodysplastiska syndrom | Sekundära myelodysplastiska syndrom | de Novo myelodysplastiska syndromFörenta staterna
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University of Colorado, DenverRekryteringKlinefelters syndrom | Trisomi X | XYY syndrom | XXXY och XXXXY syndrom | Xxyy syndrom | Xyyy syndrom | Xxxx syndrom | Xxxxx syndrom | Xxxyy syndrom | Xxyyy syndrom | Xyyyy syndrom | Man med sexkromosommosaicismFörenta staterna
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TJ Biopharma Co., Ltd.Rekrytering
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National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RekryteringMyelodysplastiska syndrom (MDS)Förenta staterna, Israel
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AbbVieCelgene; Genentech, Inc.AvslutadMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Tyskland
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AbbVieGenentech, Inc.Aktiv, inte rekryterandeMyelodysplastiska syndrom (MDS)Förenta staterna, Australien, Kanada, Frankrike, Tyskland, Italien, Storbritannien
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