- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00210730
The Duration Study
An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)
연구 개요
상세 설명
The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after completion of chemotherapy administration as compared to patients who do not receive weekly epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin alfa (PROCRIT®) treatment control (whereby patients in the control group will receive epoetin alfa (PROCRIT®) if their Hb decreases to < 10g/dL during the study) will be used to establish the frequency and magnitude of changes in clinical end points that may occur when epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be used to give every patient a greater chance to receive immediate treatment (66.6% epoetin alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The study will be powered to show differences between the two groups in hematologic response.
In this study, the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at >= 11 g/dL during the study without a Hb drop to <= 10 g/dL and/or transfusion.
The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in patients with cancer and persistent chemotherapy-induced anemia. Patients will be randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be 40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units QW). If the Hb level decreases to <= 10 g/dL, PROCRIT will be initiated at a dose of 40,000 Units QW.
연구 유형
등록 (실제)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value >= 11 g/dL and <= 12 g/dL unrelated to transfusion
- Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent
Exclusion Criteria:
- Uncontrolled hypertension
- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- Transfusion within 28 days prior to first dose
- Planned myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.
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2차 결과 측정
결과 측정 |
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Proportion of patients transfused, time to first transfusion, proportion of patients with two post baseline Hb values > 12 g/dL, mean final Hb, mean lowest Hb, proportion of patients with Hb < 10, weekly Hb, QOL
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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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