Clinical trial 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
- Conditions
- Acute lymphoblastic leukemiaMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004714-25-ES
- Lead Sponsor
- Fundación PETHEMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method