Acute lymphoblastic leukemia MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Zydelig
Pharmaceutical Form: Tablet
INN or Proposed INN: IDELALISIB
CAS Number: 870281-82-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 100-300
Sponsors
Fundación PETHEMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ??=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We intend to verify the hypothesis that Idelalisib could constitute a new therapeutic alternative for patients with ALL in a series of particularly complex cases: relapse, refractoriness to conventional treatments and old age. For this reason, the main objective is the determination of the overall response rate [GFR, defined as complete response (CR) or CR with partial hematological recovery (RCh)] and the duration of the response (RD) in adult patients with ALL. in relapse, refractory or in elderly people unfit to be treated with conventional therapies.;Secondary Objective: • Determine the GRT in different subgroups of ALL (Ph + and Ph-). • Determine disease-free survival (SLE). • Determine overall survival (SG). • Value the safety of the treatment.;Primary end point(s): • Percentage of patients that reach the TRG, defined as CR and RCh. • DR in adult patients with R / R ALL or in elderly patients with ALL not suitable to be treated with conventional therapies.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • TRG in different subgroups of ALL (Ph + and Ph-). • SLE. • SG. • Treatment safety degree;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Spain
Contacts
Public ContactDr. Juan José Lahuerta Palacios
Fundación PETHEMA
Outcome results
None listed