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Trial record 66 of 308 for:    IBRUTINIB

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

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ClinicalTrials.gov Identifier: NCT02670317
Recruitment Status : Terminated (GA101-CHOP not advantage from rituximab-CHOP)
First Posted : February 1, 2016
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief 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.


Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: Obinutuzumab Drug: Ibrutinib Drug: CHOP Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Experimental: G CHOP 21 + Ibrutinib
Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
Drug: Obinutuzumab
Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
Other Name: GA101

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

Drug: CHOP
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.
Other Names:
  • Cyclophosphamide, doxorubicin, vincristine, and prednisone
  • Hydroxydaunomycin, Oncovin




Primary Outcome Measures :
  1. The efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS (progression-free survival) [ Time Frame: 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 [ Time Frame: 5 months of treatment ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 years ]
  2. Complete Remission (CR) Rate [ Time Frame: 6 months ]
  3. Overall Response Rate (ORR) [ Time Frame: 6 months ]
  4. The Duration Of Response (DOR) after the end of treatment [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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%
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670317


Locations
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Italy
IRCCS Candiolo - Fondazione del Piemonte per l'oncologia
Candiolo, TO, Italy
AO SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
AOU Policlinico Consorziale
Bari, Italy
AO Papa Giovanni XXIII
Bergamo, Italy
Ospedale di Bolzano
Bolzano, Italy
Ospedale Businco
Cagliari, Italy
AO di Cosenza
Cosenza, Italy
AOU Careggi
Firenze, Italy
P.O. Vito Fazzi
Lecce, Italy
IRST Meldola
Meldola, Italy
Ospedale Papardo
Messina, Italy
Istituto Europeo Oncologico
Milano, Italy
AOU Policlinico di Modena
Modena, Italy
Ospedale San Gerardo
Monza, Italy
IRCCS Napoli Pascale
Napoli, Italy
Ospedale Maggiore della Carità
Novara, Italy
AOOR Villa Sofia Cervello
Palermo, Italy
AOU di Parma
Parma, Italy
Ospedale G. Da Saliceto
Piacenza, Italy
AOR San Carlo
Potenza, Italy
Ospedale Degli Infermi
Rimini, Italy
Policlinico Gemelli
Roma, Italy
Policlinico Umberto I
Roma, Italy
Humanitas
Rozzano, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
AOU Città Della Salute e Della Scienza Ematologia Universitaria
Torino, Italy
AOU Città Della Salute e Della Scienza SC Ematologia
Torino, Italy
AOU di Udine
Udine, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Maurizio Martelli, MD Policlinico Umberto I - Università "La Sapienza"

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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT02670317     History of Changes
Other Study ID Numbers: FIL-GALILEO
2015-005273-20 ( EudraCT Number )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fondazione Italiana Linfomi ONLUS:
DLBCL
large B cell lymphoma
NHL

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents