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Lymphoma, B-CellPhase 2FIL-GALILEONCT02670317

Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.

A Phase 2 study testing Obinutuzumab, Ibrutinib and CHOP in people with Lymphoma, B-Cell, run by Fondazione Italiana Linfomi - ETS at 29 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with ibrutinib. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
Obinutuzumab, Ibrutinib and CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
29 sitesItaly
Study dates
Sep 2016to Feb 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS)
  • Previously untreated disease
  • Age 18-60
  • Age adjusted IPI=2-3
  • Ann Arbor stage II-IV disease
  • Measurable disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions
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  • Normal blood count as defined as: absolute neutrophil count ≥1.0 × 109/L independent of growth factor support, platelet count ≥ 100,000/mm3 or ≥50,000/mm3 if bone marrow (BM) involvement independent of transfusion support in either situation
  • Normal organ functions defined as: creatinine ≤2 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft- Gault) ≥40 ml/min/1.73m2, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN; International normalized ratio (INR) < 1.5 × the ULN in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) < 1.5 × the ULN in the absence of a lupus anticoagulant"
  • Patients with occult or prior hepatitis B infection (defined as HBsAg negative, anti-HBs positive and /or anti-HBc positive) may be included if hepatitis B virus (HBV) DNA is undetectable. These patients must be willing to undergo bi-monthly DNA testing and they should receive prophylaxis with Lamivudine
  • No active hepatitis C virus (HCV) infection
  • Known availability of biopsy material
  • No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
  • Absence of active infections
  • Non peripheral neuropathy or active neurological non neoplastic disease of CNS
  • Non major surgical intervention prior 3 months to enrolment if not due to lymphoma and/or not other disease life-threatening that can compromise chemotherapy treatment
  • Patient with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study.
  • Patients with any other malignancy that has been treated with surgery alone with curative intent and the malignancy has been in remission without treatment for at least 5 years prior to enrolment.
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 6 months after the last dose of study drug. For males, these restrictions apply for 6 months after the last dose of study drug.
  • Women of childbearing potential must have a negative serum (betahuman chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
  • Life expectancy > 6 months
  • Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Who cannot join

  • Any Other histologies than Diffuse Large B- Cell Lymphoma (DLBCL): composite or transformed disease and patients with follicular lymphoma IIIB
  • Primary mediastinal lymphoma (PMBL)
  • Known central nervous system lymphoma
  • Any prior lymphoma therapy
  • Contraindication to any drug in the chemotherapy regimen
  • Left ventricular ejection fraction (LVEF) < 50%
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  • Neuropathy ≥ grade 2
  • Seropositive for or active viral infection with HBV
  • HBsAg positive
  • HBsAg negative, anti-HBs positive and /or anti-HBc positive with detectable viral DNA
  • Known seropositive active HCV
  • Human immunodeficiency virus (HIV) infection
  • Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): creatinine ≥ 2 times the ULN (unless creatinine clearance normal, or calculated creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula); AST or ALT ≥3 × the ULN; total bilirubin >1.5 × the ULN: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN; INR > 1.5 × the ULN in the absence of therapeutic anticoagulation; PTT or aPTT > 1.5 × the ULN in the absence of a lupus anticoagulant"
  • History of stroke or intracranial hemorrhage within the past 6 months.
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A inhibitors
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
  • Vaccinated with live, attenuated vaccines within 4 weeks of enrollment
  • Presence of major neurological disorders
  • any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
  • Major surgical intervention prior 4 weeks to enrollment if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment
  • Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
  • Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
  • If female, the patient is pregnant or breast-feeding

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Italy29 sites

  • AO SS. Antonio e Biagio e C. Arrigo

    Alessandria, 15121

  • AOU Policlinico Consorziale

    Bari

  • AO Papa Giovanni XXIII

    Bergamo

  • Ospedale di Bolzano

    Bolzano

  • Ospedale Businco

    Cagliari

  • IRCCS Candiolo - Fondazione del Piemonte per l'oncologia

    Candiolo, TO

  • AO di Cosenza

    Cosenza

  • AOU Careggi

    Florence

  • P.O. Vito Fazzi

    Lecce

  • IRST Meldola

    Meldola

  • Ospedale Papardo

    Messina

  • Istituto Europeo Oncologico

    Milan

  • AOU Policlinico di Modena

    Modena

  • Ospedale San Gerardo

    Monza

  • IRCCS Napoli Pascale

    Naples

  • Ospedale Maggiore della Carità

    Novara

  • AOOR Villa Sofia Cervello

    Palermo

  • AOU di Parma

    Parma

  • Ospedale G. Da Saliceto

    Piacenza

  • AOR San Carlo

    Potenza

  • Ospedale Degli Infermi

    Rimini

  • Policlinico Gemelli

    Roma

  • Policlinico Umberto I

    Roma

  • Humanitas

    Rozzano

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • AOU Città Della Salute e Della Scienza Ematologia Universitaria

    Torino

  • AOU Città Della Salute e Della Scienza SC Ematologia

    Torino

  • AOU di Udine

    Udine

  • Ospedale di Circolo e Fondazione Macchi

    Varese

Other trials in Italy

About this study

Official title: Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients.

This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL).

Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with ibrutinib.

Read the detailed description

This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (age-adjusted International Prognostic Index, aaIPI, 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL).

Patient will receive 6 courses of G-CHOP21 (Obimutizumab- cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone) followed by 2 doses of Obinutuzumab supplemented with Ibrutinib. Duration of treatment will be 5 months plus 4-5 weeks for response evaluation.

During the study, disease status will be evaluated after the 4th cycle by computed tomography (CT) scan, and after end of treatment by imaging test (18FDG-PET [positron emission tomography] and CT scan).

Patients will be recruited over 2 years and followed for a minimum of 2 years after the end of the treatment phase.

Being tested
Obinutuzumab, Ibrutinib, CHOP
Keywords
DLBCL, large B cell lymphoma, NHL
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called GA101

    Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

  • IbrutinibDrug

    Also called Imbruvica

    Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

  • CHOPDrug

    Also called Cyclophosphamide, doxorubicin, vincristine, and prednisone, Hydroxydaunomycin, Oncovin

    Patients will receive a maximum of 6 courses of CHOP-21 in combination with Obinutuzumab (G) followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

Study groups in NCT02670317
Study groupRoleWhat they receive
G CHOP 21 + IbrutinibExperimentalPatients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
Receives: Drug: Obinutuzumab; Drug: Ibrutinib; Drug: CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS (progression-free survival)

    Measured: 2 years

  2. The safety of G-CHOP-21 in combination with Ibrutinib in terms of proportion of patients experiencing grade 3 or greater extra-hematologic toxicity or treatment interruption for safety reasons or any toxic death during the 6 cycles of treatment

    Measured: 5 months of treatment

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: 2 years

  2. Complete Remission (CR) Rate

    Measured: 6 months

  3. Overall Response Rate (ORR)

    Measured: 6 months

  4. The Duration Of Response (DOR) after the end of treatment

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Why it stopped: GA101-CHOP not advantage from rituximab-CHOP

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670317
Sponsor's protocol ID
FIL-GALILEO
Other IDs
2015-005273-20, 2015
Acronym
FIL-GALILEO
Status last verified
Mar 2017
First submitted
25 Jan 2016
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab, Ibrutinib and CHOP in people with Lymphoma, B-Cell, run by Fondazione Italiana Linfomi - ETS at 29 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: GA101-CHOP not advantage from rituximab-CHOP). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS (progression-free survival) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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