Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

MRD negative bone marrow after maximum 24 cycles of (planned) venetoclax and no progression according to IWCLL criteria at any earlier timepoint

Secondary Outcomes (10)

Efficacy as assessed by additional outcome measures, including overall response, PFS, EFS and OS
MRD in blood
Toxicity of venetoclax after pre-induction, especially tumorlysis and neutropenia
Quality of life
Geriatric assessment
+5 more secondary outcomes

Interventions

VenetoclaxType 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
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.
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
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

Ingredients named in source formulations

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

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

Eligibility Criteria

Sexall

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

You may qualify if:

Diagnosis of symptomatic CLL (according to IWCLL guidelines)
Patients without prior treatment for CLL (Corticoid treatment administered due to necessary immediate intervention is allowed; within the last 10 days before start of study treatment only dose equivalents of max 20 mg prednisolone are permitted)

Sponsors & Collaborators

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (25)

Isala Klinieken Stichting

Zwolle, 8025 AB, Netherlands

L. Laterveer+31107041560 hovon@erasmusmc.nl

Amphia Hospital

Breda, 4818 CK, Netherlands

M. van der Klift+31107041560 hovon@erasmusmc.nl

Noordwest Ziekenhuisgroep Stichting

Alkmaar, 1815 JD, Netherlands

H.P.J. visser+31107041560

Central Study Contacts

HOVON

+31107041560 hovon@erasmusmc.nl

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 17, 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: 2024-511048-22-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:37:59 UTC

Documents

HO139_2024-511048-22-00_ Lay Summary Study Results 20AUG2026

GIVE trial (Gazyvaro In combination with VEnetoclax in Elderly CLL)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

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 (10)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations