EUCTR2005-002882-35-BE进行中（未招募）不适用
Phase I study of Src/Abl tyrosine kinase inhibitor dasatinib [BMS-354825] in children and adolescents with relapsed or refractory leukemia, Protocol ITCC 005.Revised Protocol #4, incorporating Amendments 01, 02, 03 and 04 - Protocol ITCC 005
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis [see §3.2.1 for definitions of resistance and intolerance]:
- •a) Stratum 1: Ph+ chronic myeloid leukemia in chronic phase with resistant or progressive disease during, or intolerance to, imatinib, including:
- •- failure to achieve, or loss of, complete hematologic response after =3 months of imatinib
- •- failure to achieve major cytogenetic response [= 35% Ph+ metaphases] after = 6 months or complete cytogenetic response [0% Ph+ metaphases] after = 12 months of imatinib
- •- recurrence of Ph+ clone with > 35% abnormal metaphases after prior major cytogenetic response to imatinib
- •- increase in BCR-ABL signal by quantitative PCR of = 1 log, confirmed at = 6
- •week interval [must be discussed with Principal Investigator]
- •[Note: subjects enrolled in Stratum 1 should have an ongoing search for an identical HLA donor while on study]
- •b) Stratum 2/3: i) Ph+ advanced phase CML (accelerated phase (AP), myeloid blast phase (MBP), lymphoid blast phase (LBP)) resistant to imatinib; or
- •ii) Relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ALL) after imatinib;
- •iii) Ph+ acute myeloid leukemia (Ph+AML) in second or subsequent relapse
- •(= 25% blasts in bone marrow) after prior imatinib.
- •[Note: For Strata 1 and 2/3: It is not required that imatinib be the most recent treatment. In addition, biopsy-proven isolated extramedullary leukemia, i.e. with negative BM, is permitted for all strata after discussion with Prinicipal Investigator]
- •c) Stratum 4: Ph-negative acute leukemia, any cytopathologic subtype, in second or subsequent relapse [= 25% blasts in bone marrow] or refractory after 2 or more induction regimens and for whom no therapy of greater curative potential is available.
- •2. Age =1 and <21 years
- •3. Lansky or Karnofsky scale =60 (see protocol Appendix 1)
- •4. Life expectancy >3 weeks
- •5. Serum Ca2+ levels above institutional lower limit of normal; Na, K, Mg, Phos, AST, ALT, and Bilirubin = Grade 1, and BUN and Creatinine = Grade 2.
- •6. No organ toxicity = Grade 2 (except alopecia), and recovered from acute toxicity of previous therapy
- •7. Able to comply with scheduled follow-up at one of the centers involved in this study
- •8. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
- •WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized.
- •9. Written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects for whom potentially-curative therapy is available, including electing immediate [i.e. planned < 45 days] stem-cell transplantation. Subjects in Stratum 1 should have an ongoing identical HLA donor search, and may discontinue study if a donor becomes available.
- •2. In contrast with patients with asymptomatic CNS disease (who are eligible), patients with symptomatic extramedullary leukemia are to be excluded. i.e., patients who have overt clinical symptoms (eg, convulsions) that are due to their CNS disease.
- •3. Any serious uncontrolled medical disorder that would impair the ability of the subject to receive protocol therapy, including
- •a) Ongoing uncontrolled infection
- •b) Not recovered from acute toxicity of previous therapy
- •c) Clinically-significant disorder of platelet function or ongoing gastrointestinal bleeding
- •d) Clinically-significant cardiovascular disease, congenital long QT syndrome, history of ventricular arrhythmias or heart block, or prolonged QTc interval >450 ms (Fridericia correction) on baseline electrocardiogram
- •4. Expected non-compliance or unable to have regular follow-up due to psychological, social, familial or geographic reasons
- •5. Subjects who have received:
- •a) Any investigational agent or any other anti-cancer agent within 14 days prior to treatment start. Imatinib mesylate may be continued up to 7 days before treatment start, or, in the presence of rising peripheral blast cells, imatinib may be continued up to 2 days before treatment start. If required for control of peripheral blast cells, hydroxyurea, corticosteroids, 6-mercaptopurine or 6-thioguanine may be given up to 2 days before treatment start. For concomitant use of corticosteroids, anagrelide or hydroxyurea, see §6.4.3.
- •b) Any prior therapy with dasatinib
- •6. Subjects requiring ongoing medications which
- •a) irreversibly inhibit platelet function, or anticoagulants [see Protocol section 6.4.1].
- •b) have a known risk of causing QTc prolongation [see Protocol section 6.4.1]
- •7. WOCBP with a positive pregnancy test prior to study drug administration, or who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the study, or who are pregnant or
- •breastfeeding
- •8. Prisoners or subjects who are compulsorily detained
研究者
相似试验
进行中（未招募）
1 期
Study of BMS-354825 in Children and Adolescents With Relapsed or Refractory LeukemiaEUCTR2005-002882-35-DEBristol-Myers Squibb International Corporation56
进行中（未招募）
1 期
Study of BMS-354825 in Children and Adolescents With Relapsed or Refractory LeukemiaChildren and adolescents with CML in chronic, accelerated or blast phase who are resistant or intolerant to imatinib, or in first or subsequent relapse of Ph+ ALL after prior imatinib, or in second or subsequent relapse of other ALL or AMLMedDRA version: 14.1Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 100000004864EUCTR2005-002882-35-ATBristol-Myers Squibb International Corporation58
进行中（未招募）
不适用
Phase I study of Src/Abl tyrosine kinase inhibitor dasatinib [BMS-354825] in children and adolescents with relapsed or refractory leukemia, Protocol ITCC 005. Revised protocol #4, incorporating Amendments 01, 02, 03, and 04. - Protocol ITCC 005EUCTR2005-002882-35-ITBRISTOL-M.SQUIBB56
进行中（未招募）
1 期
Study of BMS-354825 in Children and Adolescents With Relapsed orRefractory LeukemiaEUCTR2005-002882-35-GBBristol-Myers Squibb International Corporation56
进行中（未招募）
1 期
A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion CancersEUCTR2017-004246-20-DEBayer Consumer Care AG186