Trials Sponsors Conditions Drugs Pricing

Conditions

small lymphocytic lymphoma (SLL)chronic lymphocytic leukemia (CLL)

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)

Secondary Outcomes (8)

Measurable residual disease (MRD) levels by different types of measurement from different materials at final restaging (performed 3 months after end of treatment in all patients - except for patients that show progression of CLL disease or Richter transformation before this point of time - which differs depending on the duration of treatment) and selected other time points during and after treatment
Overall response rate (ORR) and complete response (CR) rate at the final restaging and selected other time points
Duration of response (DOR)
Time to next treatment (TTNT)
Treatment-free survival (TFS)
+3 more secondary outcomes

Interventions

Gazyvaro 1,000 mg concentrate for solution for infusion.Type not reported

VenetoclaxType not reported

PIRTOBRUTINIBType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Gazyvaro 1,000 mg concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Venetoclax
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
PIRTOBRUTINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Venetoclax
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Venetoclax
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Gazyvaro 1,000 mg concentrate for solution for infusion.
Named ingredient: obinutuzumab
View registry record
Venetoclax
Named ingredient: venetoclax
View registry record
PIRTOBRUTINIB
Named ingredient: pirtobrutinib
View registry record
Venetoclax
Named ingredient: venetoclax
View registry record
Venetoclax
Named ingredient: venetoclax
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Documented CLL/SLL requiring treatment according to iwCLL criteria with a CLL phenotype cell count >10-2 tracked by flow cytometry at screening.
Adequate bone marrow function as indicated by: - an absolute neutrophil count ≥ 1 x 10⁹/l - a hemoglobin value ≥8.0 g/dL without transfusions during the last 7 days unless directly attributable to CLL/SLL (e.g. bone marrow infiltration) and - a platelet count ≥ 25 x 10⁹/l unless due to the CLL/SLL, in this case, platelet count should be ≥ 10.000/µl without transfusion during the last 7 days.

Sponsors & Collaborators

University Of Cologne
Otherlead

Study Sites (154)

Beaumont Hospital

Dublin 9, D09 V2N0, Ireland

Patrick Thornton+35318092372 patrickthornton@beaumont.ie

Cork University Hospital

Cork, T12 DC4A, Ireland

Derville O'Shea+35321490029 derville.oshea@hse.ie

St James's Hospital

Dublin 8, D08 NHY1, Ireland

Carmel Waldron+35314103000

Central Study Contacts

Paula Cramer

004922147888220 cll-18@uk-koeln.de

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

November 26, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-510294-34-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:30:17 UTC

Documents

K1_Recruitment Arrangements_IE

You may not qualify if:

Any prior CLL- or SLL-specific therapies, except for corticosteroid treatment administered due to necessary immediate intervention (within the last 10 days before start of study treatment only dose equivalents up to 20 mg prednisolone per day are permitted).
Decompensated auto-immune cytopenia (defined as ongoing drop in hemoglobin (AIHA) or in platelets (ITP) in spite of prednisolone and/or intravenous immunoglobulins treatment).
(Suspicion of) transformation of CLL/SLL (i.e. Richter`s transformation) or central nervous system (CNS) involvement.
(Suspicion of) progressive multifocal leukoencephalopathy (PML).
Malignant neoplasm other than CLL/SLL unless in remission and unlikely to adversely impact on patient´s life expectancy, defined as curatively treated non-melanoma skin cancer or other neoplasias treated curatively ≥1 year ago, without signs of progression and not currently requiring systemic therapies (with the exception of ongoing anti-hormonal therapy).
Active infection requiring systemic treatment, including HIV, HBV and HCV
Increased risk of bleeding, e.g. due to: - known bleeding disorder - anticoagulant therapy with phenprocoumon or other vitamin K antagonists (anticoagulation with a direct oral Xa or thrombin inhibitor (DOAC) or heparin) is permitted) - major surgery ≤4 weeks prior to randomization - stroke or intracranial hemorrhage ≤ 6 months of randomization
Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4 or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion - could compromise the patient`s safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tab-lets or impaired resorption in the gastrointestinal tract)
Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)
Fertile men or women of childbearing potential unless: - surgically sterile or ≥ 2 years after the onset of menopause, or - willing to use two methods of reliable contraception including one highly effective (Pearl Index <1) and one additional effective (barrier) method during study treatment and for the required time period thereafter (at least one and up to 18 months after end of study treatment depending of study drug(s) used, see chapter 2.2.2.1 Known risks relevant with all study drugs).
Vaccination with a live vaccine ≤ 28 days prior to registration
Use of investigational agents which might interfere with the study drug within 28 days prior to registration
Legal incapacity
Prisoners or subjects who are institutionalized by regulatory or court order
Persons who are in dependence to the sponsor or an investigator

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (154)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (154)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations