- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02084563
Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms
Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms
The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.
Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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SP
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Sao Paulo, SP, 브라질, 05651901
- Hospital israelita Albert Einstein
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Acute Myeloid Leukemia-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Performance status (ECOG) between 0-2
- Adequate liver and kidney function
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- New York Heart Association class III and IV congestive heart failure
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Acute Myeloid Leukemia-Non-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Non-eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Chronic Myeloid Disorders:
Inclusion Criteria:
- Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
Exclusion Criteria:
- Patient refuses to sign informed consent form
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: AML-Intensive Chemotherapy
Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days. Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk:
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Induction chemotherapy for patients with AML eligible for intensive chemotherapy:
다른 이름들:
Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors: -Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles
다른 이름들:
Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
다른 이름들:
Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML Conditioning regimen:
다른 이름들:
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다른: AML-Non-intensive chemotherapy
Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs. Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory. |
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
다른 이름들:
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
다른 이름들:
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간섭 없음: Chronic Myeloid Disorders
Patients with Chronic Myeloid Disorders:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of molecular and cytogenetic abnormalities
기간: 2 years
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As assessed by results of molecular and cytogenetic tests and frequency in the population studied
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival
기간: 5 years
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Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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Response rate
기간: 1 month
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Evaluate complete remission (CR) rate at 1 month for patients with Acute Myeloid Leukemia who received induction chemotherapy.
Complete remission was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L neutrophils and >100x10^9/L platelets in the peripheral blood (PB)
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1 month
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Disease Free Survival
기간: 5 years
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Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy
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5 years
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Cumulative incidence of relapse and non-relapse mortality
기간: 5 years
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Evaluate 5-years cumulative incidence of relapse and non-relapse mortality in patients with Acute Myeloid Leukemia who achieve complete remission following induction chemotherapy
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5 years
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Number of participants with adverse events as a measure of safety and tolerability
기간: 1 year
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Evaluate hematological and non-hematological toxicity in patients with Acute Myeloid Leukemia treated according to the protocol.
Toxicity will be graded as per the National Cancer Institute Common Toxicity Criteria for Adverse Events v4.0.3
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1 year
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Cumulative Incidence of Transformation to Acute Myeloid Leukemia
기간: 5 years
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Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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공동 작업자 및 조사자
수사관
- 연구 책임자: Fabio P Santos, MD, Hospital israelita Albert Einstein
- 연구 의자: Nelson Hamerschlak, MD, PhD, Hospital israelita Albert Einstein
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LMA Brasil
- 11/1714 (기타 식별자: HIAE CEP)
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