進行中(不再收案) NCT03007147

Imatinib mesylate聯合化療用於治療新診斷費城染色體陽性急性淋巴細胞白血病患者

白血病Phase III

這項隨機第三期試驗研究imatinib mesylate聯合兩種不同化療方案在治療新診斷費城染色體陽性急性淋巴細胞白血病(ALL)患者中的效果。研究顯示,當imatinib mesylate與強效化療同時使用時,可改善費城染色體陽性(Ph+)ALL兒童及青少年的治療結果,但該聯合方案有許多副作用。

適應症:Acute Lymphoblastic Leukemia、B Acute Lymphoblastic Leukemia、Mixed Phenotype Acute Leukemia、T Acute Lymphoblastic Leukemia

收案條件

納入條件

  • For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
  • For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
  • In addition, laboratory reports detailing evidence of BCR::ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment
  • \>= 1 year (365 days) and =\< 21 years at ALL diagnosis
  • Ph+ (BCR::ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization \[WHO\] definition) with definitive evidence of BCR::ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies
  • ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (\[FISH\], e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] or similar)
  • Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
  • Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine
  • Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
  • ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase)
  • ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
  • Direct bilirubin =\< 2.0 mg/dL
  • Shortening fraction of \>= 27% by echocardiogram
  • Ejection fraction of \>= 50% by radionuclide angiogram or echocardiogram
  • Corrected QT interval, QTc \< 480 msec
  • Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or serum creatinine within normal limits based on age/gender, as follows:
  • to \< 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
  • to \< 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
  • to \< 10 years: maximum serum creatinine 1 mg/dL (both male and female)
  • to \< 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
  • to \< 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
  • \>= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

排除條件

  • Known history of chronic myelogenous leukemia (CML)
  • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
  • Down syndrome
  • Pregnancy and breast feeding
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol
  • Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
  • Prior treatment with dasatinib, or any TKI other than imatinib

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。