Phase I-II trial, open and nonrandomized, to assess the role of Idelalisib in patients with acute lymphoblastic leukemia (ALL) relapsed or refractory to other treatments, and in elderly patients with ALL in which it is advised against the use of conventional therapies - REALIB

Fundación PETHEMA0 个研究点目标入组 24 人开始时间: 2018年5月21日最近更新: 2021年5月17日

适应症

试验速览

暂无简介。

•1. Age =18 years.
•2. ALL of B cell precursors, in any of the following cases:
•a) Second or subsequent relapses [including relapse after transplantation of hematopoietic progenitors (TPH)], in patients not candidates for a later TPH.
•b) Resistance to at least two treatment lines. Treatment line is understood as initial treatment and rescue treatment after first relapse (which may include HSCT).
•c) Elderly patients (age> 65 years) in whom standard therapies are clinically discouraged.
•3. In patients with Ph + ALL, failure after receiving at least two treatments with different TKI (tyrosine kinase inhibitors): imatinib, dasatinib or ponatinib, in patients not candidates for a later TPH
•4. ECOG between 0 and 2.
•5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ??<2 times the upper limit of normal (ULN) and total bilirubin <2 mg / dL.
•6. Creatinine <2 mg / dL.
•7. More than 10% of blasts in the bone marrow in the two weeks prior to the start of the trial.
•8. Negative pregnancy test
•Are the trial subjects under 18? no
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1. Isolated relapse in the central nervous system.
•2. Patients in whom a TPH is planned.
•3. Active infection.
•4. Active grade II-IV diarrhea.
•5. Active grade II-IV hepatic toxicity.
•6. Having previously received treatment with other PI3K / mTOR inhibitors.
•7. Being, at the time of entry into the trial, receiving another experimental drug. The inclusion of patients who have completed the 4 week washout period will be allowed.
•8. Be, at the time of entry into the trial, receiving other antineoplastic drugs (except for patients who are being treated with hydroxyurea or glucocorticoids, which will be allowed to use up to 24 hours before the start of therapy with Idelalisib).
•9. Patients being treated with inhibitors or inducers of CYP3A4, whether they have a moderate or potent effect.
•10. Patients with Stevens-Johnson syndrome and toxic epidermal necrolysis.
•11. Patients with chronic active hepatitis including viral hepatitis.
•12. Patients with HIV.

发起方

Fundación PETHEMA