- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01534702
Dose Escalation of Clofarabine in Combination With Cytarabine and Idarubicin as Induction Therapy in High Risk AML (CIARA)
Phase I/II Study on Cytarabine and Idarubicin Combined With Escalating Doses of Clofarabine as Induction Therapy in Patients With Acute Myeloid Leukemia and High Risk for Induction Failure (AMLSG 17-10)
연구 개요
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Düsseldorf, 독일, 40225
- 아직 모집하지 않음
- Universitätsklinikum Düsseldorf
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연락하다:
- Andrea Kuendgen, MD
- 이메일: andrea.kuendgen@med.uni-duesseldorf.de
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수석 연구원:
- Andrea Kuendgen, MD
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Essen, 독일, 45239
- 모병
- Klinikum Essen-Werden
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연락하다:
- Mohammad Wattad, MD
- 이메일: m.wattad@kliniken-essen-sued.de
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수석 연구원:
- Mohammad Wattad, MD
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Freiburg, 독일, D-79106
- 모병
- Universitätsklinikum Freiburg
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연락하다:
- Michael Luebbert, MD
- 이메일: luebbert@mm11.ukl.uni-freiburg.de
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수석 연구원:
- Michael Luebbert, MD
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Hamburg, 독일, 20246
- 아직 모집하지 않음
- Universitätsklinikum Hamburg-Eppendorf
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연락하다:
- Walter Fiedler, MD
- 이메일: fiedler@uke.uni-hamburg.de
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수석 연구원:
- Walter Fiedler, MD
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Hannover, 독일, D-30625
- 모병
- Hannover Medical School
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연락하다:
- Juergen Krauter, MD
- 전화번호: +49-511-532-3720
- 이메일: Krauter.Juergen@MH-Hannover.de
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수석 연구원:
- Juergen Krauter, MD
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Muenchen, 독일, 81675
- 아직 모집하지 않음
- Klinikum rechts der Isar
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연락하다:
- Justus Duyster
- 이메일: justus.duyster@lrz.tum.de
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수석 연구원:
- Justus Duyster, MD
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Ulm, 독일, 89081
- 아직 모집하지 않음
- Universitätsklinikum Ulm
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연락하다:
- Richard Schlenk, MD
- 이메일: Richard.Schlenk@uniklinik-ulm.de
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수석 연구원:
- Richard Schlenk, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients with newly diagnosed AML according to WHO classification and aged ≥ 18 years eligible for an intensive induction chemotherapy with with the following characteristics:
- absence of a t(15;17), t(8;21), inv(16)/t(16;16) and the respective fusion transcripts PML-RARA, RUNX1-RUNX1T1 and CBFB-MYH11
- absence of an activating FLT3-mutation (FLT3-ITD or TKD-mutation)
- absence of an NPM1 exon12 mutation
- Written informed consent
- No previous cytotoxic chemotherapy for the treatment of AML (exception: oral hydroxyurea for up to 5 days during screening/baseline to control hyperleukocytosis)
Adequate renal and hepatic functions as indicated by the following laboratory values:
- Serum creatinine > upper limit of normal (ULN) or glomerular filtration rate (GFR) > 60 mL/min/1.73 m2, respectively
- Serum bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT/SGPT) < 2.5 x ULN
- Alkaline phosphatase (ALP) < 2.5 x ULN
- Capable of understanding the investigational nature, potential risks and benefits of the study
- Women of childbearing potential must have a negative serum pregnancy test with a sensitivity of at least 25 MIU/ml within 72 hours prior to start of IMP treatment
Female patients must meet one of the following criteria:
- For female patients > 50 years of age at the day of inclusion: Menopause since at least 1 year
Female patients < 50 years of age at the day of inclusion who meet all of the following criteria:
- menopause since at least 1 year
- serum FSH levels > 40 MIU/mL
- serum estrogen levels < 30 pg/ml or negative estrogen test
- 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
- Correct use of two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide. In case the patient takes hormone preparations for suppression of menstruation during the period of aplasia, a suitable and effective method of contraception has to be discussed with the investigator and used by the patient
- General sexual abstinence from the time of screening/baseline, during the study until a minimum of 90 days after the last administration of study medication
- Having only female sexual partners
- Monogamous relationship with sterile male partner
Male patients must meet one of the following criteria:
- 6 weeks after surgical sterilization by vasectomy
- Correct use of two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an IUD with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide.
- General sexual abstinence from the time of screening/baseline, during the study until a minimum of 90 days after the last administration of study medication
- Having only male sexual partners
- Monogamous relationship with sterile female partner
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy or immunotherapy not defined in the study protocol
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of oral hydroxyurea. The patient must have recovered from all non-hematological acute toxicities from any previous therapy
- Participation in a clinical trial within 30 days before inclusion in this study or concurrent to this study.
- Bleeding disorder independent of AML
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection (defined as persistent disease signs/symptoms without improvement despite appropriate antibiotics or other treatment)
- HIV Infection
- Pregnant or lactating women
- Any significant concurrent disease, illness, psychiatric disorder or history of serious organ dysfunction that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Diagnosis of another malignancy, unless the patient is disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
- Myelodysplastic syndrome (MDS) in patients with AML after MDS according to the WHO classification
- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
- Known hypersensitivity to any of the investigational medical products
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 치료
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Treatment is stratified according to patients age (< 60 years vs. ≥ 60 years). Medication: Patients < 60 years:
Patients ≥ 60 years:
Clofarabine will be given in escalating doses to cohorts of at least three patients: Clofarabine:
Patients will be recruited according to a 3+3 design. New cohorts will be initiated depending on toxicity of the previous cohort during the first induction cycle. Enrollment will begin with dose level 1. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin
기간: six weeks
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maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin in the therapy of previously untreated AML and high risk for induction failure
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six weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
complete remission rate
기간: 12 weeks
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complete remission rate after two cycles of induction therapy
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12 weeks
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relapse-free, event-free and overall survival
기간: 4 years
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4 years
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blast reduction in the bone marrow after the first induction cycle
기간: 15 days
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15 days
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duration of aplasia
기간: 12 weeks
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12 weeks
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therapy-associated morbidity and mortality
기간: 12 weeks
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12 weeks
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course of molecular and cytogenetic markers during chemotherapy
기간: four years
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molecular and cytogenetic markers will be evaluated by cytognetic analysis and molecular techniuques (e.g.
RT-PCR)
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four years
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fraction of patients who receive an allogeneic stem cell transplantation in first complete remission
기간: four years
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four years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Juergen Krauter, MD, Hannover Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
- KS-2009-003
- 2010-021719-18 (EudraCT 번호)
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. .
급성 골수성 백혈병에 대한 임상 시험
clofarabine, cytarabine, idarubicin에 대한 임상 시험
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University Hospital, Montpellier빼는
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The First Affiliated Hospital with Nanjing Medical...Huai'an First People's Hospital; Yancheng First People's Hospital모병
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Assistance Publique - Hôpitaux de ParisFrench Innovative Leukemia Organisation; Acute Leukemia French Association완전한
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CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co....모병
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CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co....알려지지 않은
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University of Maryland, BaltimoreHematologics, Inc모병
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University Hospital MuensterCelgene Corporation; Amgen완전한
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The First Affiliated Hospital of Soochow University모병