Assessment in real life between adverse events, and plasma concentrations of two drugs used in blood cancer: Ibrutinib (IMBRUVICA®) and idelalisib (ZYDELIG®)

Assessment in real life of the association and its determinants between adverse events, and plasma concentrations of two protein kinases inhibitors: Ibrutinib (IMBRUVICA®) and idelalisib (ZYDELIG®) in the treatment of hematological malignancies

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005572-17-FR

Enrollment

142

Registered

2016-04-26

Start date

2016-02-22

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological malignancies MedDRA version: 19.0 Level: PT Classification code 10025310 Term: Lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Ibrutinib Product Name: IMBRUVICA Pharmaceutical Form: Capsule, hard Trade Name: Idélalisib Product Name: ZYDELIG Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age > or = 18 - Patients with chronic Lymphocytic leukemia, Follicular lymphoma, mantle cell lymphoma treated with l’idelalisib or l’ibrutinib 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 142 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 142

Exclusion criteria

Exclusion criteria: -impossibility to perform blood sample -juridical protection

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the association between the occurrence of at least one clinically significant adverse events (severe AEs and / or CTCAE =3 and / or causing a dosage concession) and plasma concentrations of Ibrutinib and idelalisib or during the first year of treatment ;Secondary Objective: c;Primary end point(s): Occurrence of clinically significant adverse events (severe AEs and / or = CTCAE grade 3 and / or causing a dosage concession);Timepoint(s) of evaluation of this end point: 1 month of traitment, 2 months, 3 months, 6 months, 12 months or occurence of AE	—

Measure

Time frame

Main Objective: Evaluate the association between the occurrence of at least one clinically significant adverse events (severe AEs and / or CTCAE =3 and / or causing a dosage concession) and plasma concentrations of Ibrutinib and idelalisib or during the first year of treatment ;Secondary Objective: c;Primary end point(s): Occurrence of clinically significant adverse events (severe AEs and / or = CTCAE grade 3 and / or causing a dosage concession);Timepoint(s) of evaluation of this end point: 1 month of traitment, 2 months, 3 months, 6 months, 12 months or occurence of AE

—

Secondary

Measure	Time frame
Secondary end point(s): . ;Timepoint(s) of evaluation of this end point: 1 month of traitment, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months, or occurence of AE	—

Countries

France

Contacts

Public ContactCRA regulatory referant

CHU TOULOUSE

33561778490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026