A study of Ibrutinib in combination with Rituximab versus Placebo in combination with Rituximab in treatment of patients with Follicular Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

11 Apr 2017 → 10 Jun 2025

Decision date (initial)

2024-02-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pharmacyclics LLC, an AbbVie company

External identifiers

EU CT number

2023-507271-21-00

EudraCT number

2016-003202-14

ClinicalTrials.gov

NCT02947347

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma

Secondary objectives 5

1. * To evaluate whether the addition of ibrutinib to rituximab will result in improvement in investigator-assessed ORR when compared with rituximab alone in treatment naïve subjects with follicular lymphoma
2. * To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of OS
3. * To evaluate whether the addition of ibrutinib to rituximab will result in a reduction in infusion-related reactions
4. * To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of duration of response (DOR)
5. * To evaluate the safety and tolerability of ibrutinib combined with rituximab compared to rituximab alone in treatment naïve subjects with follicular lymphoma

Conditions and MedDRA coding

Follicular Lymphoma

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001397-PIP03-14

Plan to share IPD

Yes

IPD plan description

Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. * Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
2. * Measurable disease
3. * Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
4. * Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
5. * Adequate hematologic function within protocol-defined parameters.
6. * Adequate hepatic and renal function within protocol-defined parameters.
7. * ECOG performance status score of 0-2.
8. * Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator discretion should be applied.

Exclusion criteria 4

1. * Transformed lymphoma
2. * Prior treatment for follicular lymphoma
3. * Central nervous system lymphoma or leptomeningeal disease
4. * Currently active, clinically significant cardiovascular disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS)

Secondary endpoints 5

1. • Overall response rate (ORR) (Cheson 2014)
2. • Overall Survival (OS)
3. • Infusion-related reaction rate (Arm A vs. Arm B)
4. • Duration of response (DOR) as assessed by investigator
5. • Frequency, severity, seriousness, and relatedness of adverse events (AEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 5

Locations

11 EU/EEA countries · 61 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 131 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications