TRIAL OF 17-AAG AND CYTARABINE IN LEUKEMIA AND MYELODSPLASTIC SYNDROME
TRIAL OF 17-AAG AND CYTARABINE IN LEUKEMIA AND MYELODSPLASTIC SYNDROME
批准号:
7604647
负责人:
JUDITH KARP
金额:
$0.8万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-12-01 至 2007-09-16
关键词:
17-(Allylamino)-17-demethoxygeldanamycinBilirubinBlast CellBlast PhaseBone MarrowCategoriesCellularityChromosome abnormalityChromosomes, Human, Pair 5ChronicChronic Myeloproliferative DisorderComputer Retrieval of Information on Scientific Projects DatabaseContinuous InfusionCreatinine clearance measurementCytarabineCytogeneticsDiagnosticDiseaseEastern Cooperative Oncology GroupFailureFundingGrantHospitalsImatinibImatinib mesylateInfiltrationInstitutionLaboratoriesMarrowMonocytic leukemiaNeoadjuvant TherapyNon-Hematologic MalignancyOrganPatientsPerformance StatusPerformance Status 0Prior ChemotherapyRAEB-2RecoveryRelapseResearchResearch PersonnelResourcesRiskScoreSourceSyndromeTreatment ProtocolsUnited States National Institutes of HealthUpper Limit of NormalWorld Health Organizationcytopeniadayfallsleukemiaprognostictreatment planningtumor
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目及
研究者(PI)可能从另一个NIH来源获得了主要资金,
因此可以在其他CRISP条目中表示。所列机构为
研究中心,而研究中心不一定是研究者所在的机构。
肿瘤类型:AML:根据WHO诊断标准,任何非FAB M3(APL)AML必须属于以下类别之一
初始诱导方案未能达到CR
首次CR后1年内首次复发
首次或第二次复发时重新诱导治疗失败
第二或第三次复发的患者接受不超过三次 不同诱导方案
既往血液学疾病(MDS,慢性骨髓增生性疾病, 慢性骨髓单核细胞白血病)
既往接受过非血液系统恶性肿瘤化疗
高危细胞遗传学异常(染色体5、7、8或 11,或= 3核型异常)
ALL:任何属于以下类别之一的ALL
初始诱导方案未能达到CR
首次CR后1年内首次复发
首次或第二次复发时重新诱导治疗失败
第二或第三次复发的患者接受不超过三次 不同诱导方案
CML:患者骨髓中原始细胞百分比必须增加 (> 10%,即加速期或“急变期”)且伊马替尼治疗失败 甲磺酸盐患者可能只接受了一种额外的治疗方案, 除了伊马替尼治疗他们的CML。
CMML:患者必须同时具有原始细胞百分比增加(> 10%,即 CMML 2)以及器官浸润或即将发生骨髓衰竭的证据 表现为血细胞减少。此外,患者不应有t(5;12), 细胞遗传学,除非他们没有失败的试验伊马替尼甲磺酸盐。
MDS:高级别MDS患者(定义为骨髓细胞结构原始细胞>10%) (RAEB-2)或IPSS MDS预后评分>1.5)
体能状态:ECOG体能状态(PS)0、1或2。
允许的异常器官功能:在登记前≥ 7天获得以下实验室检查值:
直接胆红素=1.5 x正常上限(ULN)(除非归因于基础疾病)
肌酐清除率计算值=60 mL/min
治疗计划:阿糖胞苷400 mg/m2/天,连续输注,第1 - 5天
17-第3天和第6天,60分钟内静脉注射AAG
在骨髓恢复或出院后30至5天重复
来自上一周期
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
Tumor Types: AML: Any non-FAB M3 (APL) AML by WHO diagnostic criteria must fall into 1 of the categories below
Failure to achieve a CR with initial induction regimen
First relapse within one year of initial CR
Failure of re-induction therapy at first or second relapse
Second or third relapse in a patient who has received no more than three different induction regimens
Antecedent hematologic disorder (MDS, chronic myeloproliferative disease, chronic myelo-monocytic leukemia)
Prior chemotherapy for a non-hematologic malignancy
High risk cytogenetic abnormalities (abnormalities of chromosome 5,7,8, or 11, or = 3 karyotypic abnormalities)
ALL: Any ALL falling into one of the categories below
Failure to achieve a CR with initial induction regimen
First relapse within one year of initial CR
Failure of re-induction therapy at first or second relapse
Second or third relapse in a patient who has received no more than three different induction regimens
CML: Patients must have an increase in blast percentage in the bone marrow (>10%, i.e. either accelerated or "blast phase") and have failed imatinib mesylate. Patients may have had only one additional treatment regimen in addition to imatinib for their CML.
CMML: Patients must have both an increase in blast percentage (>10 %, i.e. CMML 2) as well as evidence of organ infiltration or impending marrow failure as manifested by cytopenias. Additionally patients should not have a t(5;12) by cytogenetics unless they have failed a trial of imatinib mesylate.
MDS: High grade MDS patients (defined as >10% blasts on marrow cellularity (RAEB-2) or IPSS MDS prognostic score of >1.5)
Performance Status: ECOG Performance Status (PS) 0, 1, or 2.
Abnormal Organ Function Permitted: The following laboratory values obtained =7 days prior to registration:
Direct bilirubin =1.5 x upper limit of normal (ULN) (unless attributable to underlying disease)
Calculated creatinine clearance =60 mL/min
Treatment Plan: Cytarabine 400 mg/m2/day continuous infusion days 1 through 5
17-AAG intravenously over 60 minutes on days 3 and 6
Repeat 30 ¿ 5 days after marrow recovery or hospital discharge
From previous cycle
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
PHASE II TRIAL OF TRIAPINE
-
批准号:7604693
-
项目类别:
-
资助金额:$1.01万
-
财政年份:2006
-
负责人:JUDITH KARP
-
依托单位:
ORAL ETOPOSIDE IN COMBINATION WITH FARNESYLTRANSFERASE INHIBITOR R115777
-
批准号:7604648
-
项目类别:
-
资助金额:$0.87万
-
财政年份:2006
-
负责人:JUDITH KARP
-
依托单位:
A PHASE I/II STUDY OF FLAVOPIRIDOL FOR ADULTS WITH LEUKEMIAS
-
批准号:7604642
-
项目类别:
-
资助金额:$6.26万
-
财政年份:2006
-
负责人:JUDITH KARP
-
依托单位:
PHASE I TRIALS OF ANTICANCER AGENTS
-
批准号:6352426
-
项目类别:
-
资助金额:$6.42万
-
财政年份:1995
-
负责人:JUDITH KARP
-
依托单位:
PHASE I TRIALS OF ANTICANCER AGENTS
-
批准号:6448472
-
项目类别:
-
资助金额:$39.12万
-
财政年份:1995
-
负责人:JUDITH KARP
-
依托单位:
PHASE I TRIALS OF ANTICANCER AGENTS
-
批准号:6164207
-
项目类别:
-
资助金额:$26.85万
-
财政年份:1995
-
负责人:JUDITH KARP
-
依托单位:
PHASE I TRIALS OF ANTICANCER AGENTS
-
批准号:2882438
-
项目类别:
-
资助金额:$13.0万
-
财政年份:1995
-
负责人:JUDITH KARP
-
依托单位:
海外基金