독소루비신 및 asparaginase (E. Coli) 및 asparaginase (Erwina)의 급성 림프구성 백혈병 - 임상 시험 레지스트리

연구 개요

상태

종료됨

정황

급성 림프구성 백혈병

개입 / 치료

상세 설명

Children with acute lymphoblastic leukemia (ALL) are treated somewhat differently depending upon on the relative risk of the leukemia recurring. For this study they are classified into "Standard Risk", "High Risk" and "Infant/High Risk".
The treatment for patients in the "Standard Risk" and "High Risk" groups consists of three phases of therapy: induction treatment; prevention of brain and spinal cord leukemia (CNS treatment); and intensification/continuation chemotherapy.
The treatment for patients in the "Infant/High Risk" group consists of four phases of therapy: induction treatment; infant intensification therapy; intensification/continuation chemotherapy; and CNS treatment.
The induction treatment consists of a combination of chemotherapy drugs whose purpose is to kill all detectable leukemia cells. This process usually requires a least one month and includes six anti-leukemia drugs. These drugs are: vincristine, doxorubicin, methotrexate, cytosine arabinoside, asparaginase and steroids (methylprednisolone or prednisone).
After the induction phase, "Infant/High Risk" patients will receive a highly intensive month of treatment (infant intensification) . Drugs used during this month include high-dose methotrexate, asparaginase, 6-mercaptopurine and high dose cytosine arabinoside (ARA-C).
CNS treatment begins during induction therapy but is intensified during the second and third month after diagnosis. Treatment for all patients will include a series of spinal taps with the instillation of anti-leukemia drugs, including cytosine arabinoside and methotrexate and with or without hydrocortisone (depending upon randomization).
All high risk patients (those in both "High Risk" and "Infant/High Risk") as well as some standard risk patients will receive radiation treatment to the brain. Radiation therapy will either be given in either "conventional" treatments (once daily for 10 days), or "hyperfractionated" treatments (twice daily at half doses for 10 days). Total dose of radiation is 1800 cGy.
Intensification and continuation therapy, begins 4-5 weeks after diagnosis for "Standard Risk" and "High Risk" groups and 4-5 weeks after infant intensification in "Infant/High Risk" group. This phase of treatment continues until the completion of two years of treatment. Patients in the "Standard Risk" group will receive five anti-leukemia drugs (vincristine, prednisone, methotrexate, asparaginase, and 6-mercaptopurine). Patients in "High Risk" and "Infant/High Risk" will receive six anti-leukemia drugs (vincristine, prednisone, doxorubicin, methotrexate, asparaginase and 6-mercaptopurine).
All patients will be able to participate in a randomization comparing two types of asparaginase, E.coli and Erwinia. Patients will be randomized to receive either once weekly E.coli or once-weekly Erwinia during the Intensification phase, each given for a total of 20 weeks.
Patients in the "Standard Risk" group are able to participate in an additional randomization. Standard risk patients will be randomized to receive one of two different regimens designed to prevent central nervous system leukemia, either 1)radiation therapy (given twice daily) with chemotherapy in the spinal fluid every 18 weeks, or 2) intensive chemotherapy in the spinal fluid alone without radiation.
Patients in the "High Risk" and "Infant/High Risk" groups are able to participate in two randomizations in addition to the asparaginase randomization. The first will be to assess whether the drug dexrazoxane prevents heart damage caused by doxorubicin without affecting risk of relapse. Patients will be randomized to receive either doxorubicin alone or doxorubicin with dexrazoxane during the induction, CNS and intensification phases. The second randomization will compare the relative efficacy and toxicity of different cranial radiation schedules. Patients will be randomized to receive radiation in either once daily or twice daily fractions.
Blood and bone marrow samples will be collected to learn more about the biology of leukemia. These samples will also be used to test minimal residual disease levels to learn if these levels help predict risk of relapse.
Quality of life questionnaires will also be performed by the parents of patients, by children over eight, and by the child's clinician.

연구 유형

중재적

등록

491

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Louisiana
  - New Orleans, Louisiana, 미국, 70121
    - Ochsner Clinic
- Maine
  - Lewiston, Maine, 미국, 04240
    - Maine Medical Center
- Massachusetts
  - Boston, Massachusetts, 미국, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, 미국, 02115
    - Children's Hospital Boston
- New York
  - New York, New York, 미국, 10029
    - Mt. Sinai Medical Center
  - Rochester, New York, 미국, 14627
    - University of Rochester
캐나다
- Ontario
  - Hamilton, Ontario, 캐나다
    - McMaster University
- Quebec
  - Montreal, Quebec, 캐나다
    - Laval University
  - Montreal, Quebec, 캐나다
    - Sainte Justine Hosptial
푸에르토 리코
- - Santurce, 푸에르토 리코, 00912
    - San Jorge Children's Hospital

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 이하 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Acute lymphoblastic leukemia, excluding known mature B-cell ALL
< 18 years of age
Patients who are leukopheresed or exchanged are eligible for study only after completion of the pheresis or exchange transfusion
Absence of a t(8,14) (q24; q32), t (8,22), t(2,8)
Total bilirubin < 1.4mg/dl

Exclusion Criteria:

Known HIV positive
Prior steroid therapy within 30 days of diagnosis
Septic shock
Ongoing intracranial hemorrhage
Clinical evidence of CNS or lung leukostasis

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: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
-To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane
-To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.
-To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase
-To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.

2차 결과 측정

결과 측정
-To compare randomized treatment groups using health-related quality of life analyses.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Dana-Farber Cancer Institute

협력자

Boston Children's Hospital

수사관

수석 연구원: Stephen E. Sallan, MD, Dana-Farber Cancer Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

1996년 1월 1일

기본 완료 (실제)

2006년 9월 1일

연구 완료 (실제)

2006년 9월 1일

연구 등록 날짜

최초 제출

2005년 9월 9일

QC 기준을 충족하는 최초 제출