SYF797f6086f9f246a7a78bf134e3a2d188

RecruitingPhase 2

Ibrutinib and Obinutuzumab as first-line treatment for patie...

Ospedale San Raffaele S.r.l.Source

Ospedale San Raffaele S.r.l.

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

6

Brief Summary

Evaluate the percentage of BM MRD <10-4 in BM at +30 days of follow-up after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 6 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 3, 2024
Actual (reported)

Conditions

chronic lymphocytic leukemia/small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy

Interventions

OBINUTUZUMABType not reported

IBRUTINIBType not reported

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

Eligibility Criteria

Sexall

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

You may qualify if:

Age >=18 years
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL) according to iwCLL diagnostic criteria
Previously untreated active disease requiring treatment according to iwCLL criteria

Sponsors & Collaborators

Ospedale San Raffaele S.r.l.
Type not reportedlead

Study Sites (6)

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Palermo, 90146, Italy

Caterina Patti0916884002 k.patti@ospedaliriunitipalermo.it

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Turin, 10126, Italy

Lorella Orsucci0116335610 lorsucci@cittadellasalute.to.it

Azienda Ospedaliera S Maria Di Terni

Terni, 05100, Italy

Anna Marina Liberati

Central Study Contacts

Paolo Ghia

0226434797 ghia.paolo@hsr.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

July 3, 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: 2024-514824-18-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:15:46 UTC

Documents

D1_Protocol

NCT06539182

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

Phase 2Recruiting

NCT07154264

A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

Phase 2Recruiting

NCT07887061

Tacabrutideg and Sonrotoclax, With Response-Guided Obinutuzumab, for the Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 2Not Yet Recruiting

NCT05007860

Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia

Completed

NCT03041636

Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2Completed

NCT07582159

Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2Not Yet Recruiting

ECOG PS 0 or 1

Lymph node disease measurable (longest diameter> 1.5 cm) by CT

Adequate blood count defined as: Absolute neutrophil count (ANC)> 750 cells / μL (750 cells / mm3 or 0.75 x 109 / L), Platelet count> 30,000 / μL (30,000 cells / mm3 or 30 x 109 / L), Hemoglobin> 8.0 g / dL

Adequate liver and kidney function defined as: Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of normal (ULN) , Estimated Creatinine Clearance (CrCl) =30 mL / min (Cockcroft-Gault), Bilirubin =1.5 x ULN (unless increased bilirubin is due to Gilbert's syndrome or of non-hepatic origin)

Prothrombin time (PT) / International normal ratio (INR) <1.5 x ULN and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are related to coagulopathy or bleeding disorder)

You may not qualify if:

Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and / or monoclonal antibody) used to treat CLL or SLL.
Patients with del (17p) and / or TP53 mutation according to centralized laboratory assessment.
History of other malignancies, except: Malignant tumor treated with curative intent and with no known active disease present for =3 prior to first dose of study drug and deemed low risk of recurrence by treating physician, Malignant skin neoplasm not adequately treated or lentigo maligna with no evidence of disease, Adequately treated carcinoma in situ with no evidence of disease.
Known or suspected history of Richter's transformation.
Known hypersensitivity to one or more study drugs.
Known bleeding disorders (eg von Willebrand disease or haemophilia).
History of stroke or intracranial haemorrhage within 6 months prior to enrollment.
Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. Individuals who are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who test positive for PCR will be excluded.
Inability to swallow capsules / tablets or malabsorption syndrome, any disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Concomitant use of warfarin or other vitamin K antagonists.
Major surgery within 4 weeks of the first dose of study drug

Contact the study team to confirm eligibility.

0744205971

ilariaangeletti@yahoo.it

Azienda Ospedaliera di Padova

Padova, 35128, Italy

Livio Trentin0498211722 livio.trentin@unipd.it

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Marina Motta3492553494 marina.motta@asst-spedalicivili.it

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Paolo Ghia0226434797 ghia.paolo@hsr.it

E1_IB_Ibrutinib

E1_IB_Obinutuzumab

Blank document_ not required under directive

L1_ICF_Redacted

Locations

IT(6)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations