Phase I study to evaluate the feasibility and safety of addition of ruxolitinib to a standard BFM-90 regimen in adolescent/adult Ph-like A

Tata Research Administrative Council TRAC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

暂无简介。

•1. Newly diagnosed Ph-like B cell precursor acute lymphoblastic leukemia
•2. Diagnostic bone marrow or peripheral blood sample must demonstrate a Ph-like expression profile with 1 of the following genetic lesions-
•a-CRLF2 overexpression by flow cytometry( >10%)
•b-CRLF2 rearrangement with fusion partners(IGH,P2RY8) or
•c-JAK2 rearrangement
•d-EPOR rearrangement
•e-PAX5 rearrangement
•f-Other JAK pathway alterations ( eg g, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) as detected by targeted RNA sequencing.
•3. ECOG PS 0-3
•4. Patients must have adequate organ and marrow function as defined below
•-Adequate liver function (SGOT/SGPT <5 times ULN, Bilirubin <2 X ULN)
•-Adequate kidney function (S. Cr < 2X ULN or Creatinine clearance > 60ml/min/1.73m2)
•-Platelet count >75000/uL
•5. Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.

•1.Patients who test positive for Ph +ve (BCR-ABL 1) / ETV6-RUNX1 / TCF3-PBX1 / MLL rearrangements / High hyperdiploidy by FISH/Conventional karyotyping
•2.Seropositivity (HIV)- Patients receiving anti-retroviral therapy
•3.Active replication of Hepatitis B virus / Hepatitis C virus
•4.Uncontrolled comorbidities (Hypertension / Diabetes Mellitus / Seizures)
•5.Pregnant patients
•6.Active uncontrolled infection
•7.Usage of strong CYP3A4 inhibitors within 5 half lives before first dose of study drug

发起方

Tata Research Administrative Council TRAC