Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To compare the pharmacokinetics of prednisone/prednisolone, vincristine, and daunorubicin hydrochloride among obese, middle-weight, and underweight children aged 10 to less than 20 years of age undergoing induction therapy for high-risk acute lymphoblastic leukemia.
II. To examine the relationship between the above parameters and response status as defined by early response and induction failure
OUTLINE: This is a multicenter study. Patients are stratified according to body mass index (BMI) (greater than or equal to 95th percentile [obese] vs 10th to 95th percentile [normal or at risk for overweight] vs less than or equal to 10th percentile [underweight]).
Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
Blood samples are obtained on either day 1 or day 8** of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine activity levels.
Blood samples are analyzed via high-performance liquid chromatography (HPLC), ultrafiltration, a Nessler reaction, ELISA, and liquid chromatography using reverse-phase chromatography, fluorescent detection, and solid-phase extraction.
Demographic information, including ethnicity, is also collected. Weight and height is recorded at diagnosis and on the day pharmacokinetic assessment of vincristine, prednisone, and daunorubicin hydrochloride begins.
NOTE: **Patients who are being sampled on day 8 of induction therapy and who have received intravenous corticosteroid therapy in the first week of induction must have received at least six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on day 8.
연구 유형
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Childrens Oncology Group
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
설명
Inclusion Criteria:
- Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin in the doses and schedule as per the current COG AALL0232 protocol; prior registration onto a COG protocol is not required
- Patients must be able to take either prednisone/prednisolone reliably by mouth on day 1 or 8 of induction (depending on sampling schedule chosen); patients who are being sampled on Induction day 8 and who have received intravenous corticosteroid therapy in the first week of induction must have received a minimum of six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on induction day 8
Exclusion Criteria:
- Serum transaminase concentrations >= 5 X ULN for age
- Total serum bilirubin (conjugated + unconjugated) >= 1.5 mg/dl (>= 26 micromol/L)
- Serum creatinine > 1.5 X ULN for age
- With the exception of prednisone/prednisolone, receipt of medications or food known or with the potential to alter the pharmacokinetics of the drugs under study within 14 days of diagnosis and throughout the period of pharmacokinetic sampling; such agents include but are not limited to: grapefruit, tangelos or the juice of these fruits; St. Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole, voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid; rifampin; verapamil; and diltiazem
- Presence of known malabsorption syndrome
- Females with known pregnancy (pregnancy test must be negative to be eligible)
공부 계획
연구는 어떻게 설계됩니까?
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Basic science (pharmacokinetics)
Patients receive anticancer therapy as prescribed by their treating clinicians.
Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
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상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
구두로 주어진
다른 이름들:
Given orally
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pharmacokinetic parameters of prednisone/prednisolone
기간: Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
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Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
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Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
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Pharmacokinetic parameters of daunorubicin hydrochloride
기간: Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
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Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
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Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
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Pharmacokinetic parameters of vincristine sulfate
기간: Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
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Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
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Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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RER and SER status
기간: Up to 1.5 years
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To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.
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Up to 1.5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ian Pollack, Children's Oncology Group
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 림프 증식 장애
- 림프계 질환
- 면역증식성 장애
- 백혈병
- 전구 세포 림프구성 백혈병-림프종
- 백혈병, 림프
- 약물의 생리적 효과
- 약리작용의 분자기전
- 자율 작용제
- 말초 신경계 작용제
- 효소 억제제
- 항염증제
- 항종양제
- 튜불린 조절제
- 항유사분열제
- 유사분열 조절제
- 항구토제
- 위장약
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 신경보호제
- 보호제
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 항생제, 항종양제
- 프레드니솔론
- 메틸프레드니솔론 아세테이트
- 메틸프레드니솔론
- 메틸프레드니솔론 헤미숙시네이트
- 프레드니솔론 아세테이트
- 프레드니솔론 헤미숙시네이트
- 프레드니솔론 인산염
- 프레드니손
- 빈크리스틴
- 다우노루비신
- 하이드로코르티손
- 하이드로코르티손 17-부티레이트 21-프로피오네이트
- 히드로코르티손 아세테이트
- 히드로코르티손 헤미숙시네이트
- 코르티손
기타 연구 ID 번호
- ACCL0631 (기타 식별자: CTEP)
- U10CA095861 (미국 NIH 보조금/계약)
- NCI-2011-02151 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- CDR0000588173
- COG-ACCL0631 (기타 식별자: DCP)
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