An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes
2016년 3월 14일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
130
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스
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Goudi-Athens, 그리스
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Larisa, 그리스
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Patra, 그리스
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Thessalonikis, 그리스
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Berlin, 독일
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Dresden, 독일
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Duisburg, 독일
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Düsseldorf, 독일
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Dÿsseldorf, 독일
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München, 독일
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Oldenburg, 독일
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Würzburg, 독일
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Ekaterinburg, 러시아 연방
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St. Petersburg, 러시아 연방
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Plovdiv, 불가리아
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Sofia, 불가리아
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Varna, 불가리아
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Amiens, 프랑스
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Angers Cedex 9, 프랑스
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Bobigny, 프랑스
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Colmar, 프랑스
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Paris Cedex 10, 프랑스
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Pessac Cedex, 프랑스
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Pierre Benite Cedex, 프랑스
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Saint Priest En Jarez, 프랑스
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Tours Cedex 9, 프랑스
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Vandoeuvre Les Nancy, 프랑스
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
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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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Erythroid response
기간: at week 24
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at week 24
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2차 결과 측정
결과 측정 |
기간 |
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Maintenance of Erythroid response
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: at baseline, week 24 and week 48
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at baseline, week 24 and week 48
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Drug consumption
기간: 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
기간: 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
기간: every 4 weeks from baseline to week 48
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every 4 weeks from baseline to week 48
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간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 10월 1일
기본 완료 (실제)
2015년 1월 1일
연구 완료 (실제)
2016년 1월 1일
연구 등록 날짜
최초 제출
2011년 6월 23일
QC 기준을 충족하는 최초 제출
2011년 6월 23일
처음 게시됨 (추정)
2011년 6월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 3월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 14일
마지막으로 확인됨
2016년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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