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Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma (GAUDEALIS)

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ClinicalTrials.gov Identifier: NCT03890289
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Idelalisib Drug: Obinutuzumab Phase 2

Detailed Description:

Single arm, prospective, multi-centric, phase II study. Patients with histologically confirmed follicular lymphoma, in need of a systemic approach and failing (i.e. with refractory disease [no response or response lasting less than 6 months at any previous line of treatment] or with a proven disease relapse) at least 2 previous lines of treatment, including any antibody directed against the CD20 antigen-containing chemotherapy, will undergo a combined chemo-free treatment with obinutuzumab and idelalisib.

Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15 of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab and on a daily 150 mg bid schedule. For patients achieving at least a partial response at the end of induction, a maintenance phase with obinutuzumab is scheduled (on day 1 every two months for two years or until progression or unacceptable toxicity, whichever comes first) If one of the two drugs has to be permanently discontinued due to any cause, patient may continue treatment with the other agent if it is judged to be a clinical benefit. Patients with at least a stable disease will enter the follow-up phase and will be followed with repeated CT scans every six months for two years or until death/progression occurs (whichever comes firsts).

Patients with progressive disease, whenever progression is documented, will enter a survival follow up period of two years after PD was documented. These patients are however considered evaluable for OS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Single arm: Regimen: GAUDEALIS q28 days

  • Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle)
  • Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward)
  • Idelalisib Dose: 150 mg BID oral Daily (24 weeks) Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on day 1, 8, 15, of the first cycle, then repeated on day 1 of each subsequent cycle, for 6 cycles in total (each cycle is completed in 28 days). Idelalisib will be given concomitantly with obinutuzumab on a daily 150 mg bid schedule orally and continuously (24 weeks).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Idelalisib Plus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: a Phase 2, Single-arm, Multicentric Study
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : October 18, 2021
Estimated Study Completion Date : October 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Idelalisib Plus Obinutuzumab

Single arm: Regimen: GAUDEALIS q28 days

  • Obinutuzumab Dose: 1000 mg IV Day 1, 8, 15 (1st cycle)
  • Obinutuzumab Dose: 1000 mg IV Day 1 (2nd cycle onward)
  • Idelalisib Dose: 150 mg BID oral Daily (24 weeks)
Drug: Idelalisib
Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma

Drug: Obinutuzumab
Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma




Primary Outcome Measures :
  1. Primary Endpoint - Overall response rate (ORR) [ Time Frame: through the completion of the study ]
    Investigator's assessed Overall response rate at the end of induction phase of patients treated with a chemo-free combination with obinutuzumab and idelalisib. Overall response rate is defined as the proportion of patients with at least a partial response


Secondary Outcome Measures :
  1. Secondary Endpoints 1 - Overall survival (OS) rate [ Time Frame: at the end of induction phase of patients treated with a chemo-free. Through the completion of the study ]
    Overall survival rate

  2. Secondary Endpoints 2 - Progression-free survival (PFS) rate [ Time Frame: at the end of induction phase of patients treated with a chemo-free. Through the completion of the study ]
    Progression-free survival rate

  3. Secondary Endpoints 3 - patients' withdrawal rate [ Time Frame: at the end of induction phase of patients treated with a chemo-free. Through the completion of the study ]
    patients' withdrawal rate, incidence and nature of any severe adverse events hospitalization rate throughout the study, and patients' compliance to oral treatment, incidence of any adverse events occurring during and right after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Relapsed or refractory, histologically confirmed CD20-positive follicular non-Hodgkin's lymphoma, grade 1, 2 or 3a according to WHO 2017 classification.

  • Age 18 ≥ years
  • At least 2 prior systemic therapies for follicular lymphoma including both any antibody directed against the CD20 antigen and a chemotherapy combination.
  • Treatment indications, with the presence of at least one of the following:

    • bulky disease (nodal or extranodal mass - except spleen -more than 7 cm in its greater diameter or involvement of at least 3 nodal or extranodal sites, each with a diameter equal to or greater than 3 cm);
    • at least one B-symptom (fever > 38°C of unclear etiology, night sweats, weight loss greater than 10% of body weight in the prior 6 months);
    • symptomatic splenomegaly;
    • compression syndrome (i.e. of orbits, ureters, gastrointestinal tract, biliary tract);
    • lymphoma-related cytopenias (hemoglobin < 10 g/dL and/or platelets < 100.000/mmc and/or neutrophils < 1.500/mmc);
    • pleural or peritoneal serous effusions;
    • lactate dehydrogenase elevation.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  • Adequate hematological function, unless abnormalities due to underlying disease, within 28 days prior to signing informed consent, defined as follows: neutrophils > 1.500/mmc, platelets > 75.000/mmc, hemoglobin > 8,0 g/dL with transfusion independence.
  • Capacity and willingness to adhere to study visit schedule and specific protocol procedures.
  • Willingness to sign a written informed consent.
  • Compliance with effective contraception without interruption, from 28 days before treatment start up (i.e., during the screening phase) to 18 months after treatment discontinuation, agreeing not to donate the semen during treatment and for 18 months after discontinuation (if the patient is male), or to undergo ongoing pregnancy test during the course of the study (if the patient is female).
  • Patients must agree to undergo JPJ prophylaxis throughout the treatment period and 2-6 months thereafter (before consulting with Medical Monitor).

Exclusion criteria

Grade 3b follicular non-Hodgkin's lymphoma or evidence of transformation to high-grade non-Hodgkin's lymphoma.

  • Central nervous system or leptomeningeal involvement by lymphoma.
  • Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.
  • Seropositivity for HBV or evidence of active infection (HBsAg positivity, or HBsAg negativity with positive anti-HBs/anti-HBc and detectable viral DNA load); if viral load is negative or undetectable, the patient is eligible, provided their HBsAg negativity.
  • Positive viral HCV RNA
  • Seropositivity for HIV, regardless of viral load.
  • Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension
  • Known history of drug induced pneumonitis
  • On-going inflammatory bowel disease
  • On-going alcohol or drug addiction
  • Life expectancy lower than 6 months.
  • Prior history of malignancies, other than follicular lymphoma, unless the patient has been free for at least 10 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix).
  • Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) > 2.5-fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance < 30 mL/min.
  • Uncontrolled intercurrent illness.
  • Known hypersensitivity or allergy to murine products or to any of the medicaments under investigation.
  • Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception.
  • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study.
  • Any evidence of ongoing bacterial, viral and fungal infection.

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): NCT03890289


Contacts
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Contact: Pierluigi Zinzani, Prof. 3385703457 - 0516364042 pierluigi.zinzani@unibo.it
Contact: Alice Di Benedetto 0131033153 adibenedetto@filinf.it

Locations
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Italy
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A Not yet recruiting
Aviano, Italy, 33081
Contact: Michele Spina, Dott.       mspina@cro.it   
Principal Investigator: Michele Spina, Dott.         
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia Not yet recruiting
Bari, Italy, 70124
Contact: Attilio Guarini, Dott.       attilioguarini@oncologico.bari.it   
Principal Investigator: Attilio Guarini, Dott.         
Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli" Not yet recruiting
Bologna, Italy, 40138
Contact: Pier Luigi Zinzani, Prof.       pierluigi.zinzani@unibo.it   
Principal Investigator: Pier Luigi Zinzani, Prof.         
ASST Spedali Civili di Brescia - Ematologia Not yet recruiting
Brescia, Italy, 25123
Contact: Giuseppe Rossi, Dott.       giuseppe.rossi@asst-spedalicivili.it   
Principal Investigator: Giuseppe Rossi, Dott.         
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia Recruiting
Firenze, Italy, 50141
Contact: Alberto Bosi, Dott.       abosi@unifi.it   
Principal Investigator: Alberto Bosi, Dott.         
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia Not yet recruiting
Milano, Italy, 20133
Contact: Paolo Corradini, Prof.       paolo.corradini@unimi.it   
Principal Investigator: Paolo Corradini, Prof.         
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica Not yet recruiting
Napoli, Italy, 80131
Contact: Antonio Pinto, Dott.       apinto.int.napoli@tin.it   
Principal Investigator: Antonio Pinto, Dott.         
AOU Maggiore della Carità di Novara - SCDU Ematologia Not yet recruiting
Novara, Italy, 28100
Contact: Gianluca Gaidano, Prof.       gaidano@med.uniupo.it   
Principal Investigator: Gianluca Gaidano, Prof.         
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione Not yet recruiting
Roma, Italy, 00161
Contact: Alessandro Pulsoni, Prof.       alessandro.pulsoni@uniroma1.it   
Principal Investigator: Alessandro Pulsoni, Prof.         
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia Not yet recruiting
Torino, Italy, 10126
Contact: Carola Boccomini, Dott.ssa       cboccomini@cittadellasalute.to.it   
Principal Investigator: Carola Boccomini, Dott.ssa         
Azienda sanitaria-universitaria integrata Trieste (ASUITS) - SC Ematologia Recruiting
Trieste, Italy, 34121
Contact: Francesco Zaja, Prof.       francesco.zaja@asuits.sanita.fvg.it   
Principal Investigator: Francesco Zaja, Prof.         
Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - SOC Clinica Ematologica Not yet recruiting
Udine, Italy, 33100
Contact: Jacopo Olivieri, Dott.       jacopo.olivieri@hotmail.it   
Principal Investigator: Jacopo Olivieri, Dott.         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Pierluigi Zinzani, Prof. Bologna - Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT03890289    
Other Study ID Numbers: FIL_GAUDEALIS
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Italiana Linfomi ONLUS:
Idelalisib
Obinutuzumab
Relapsed/Refractory Follicular Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Obinutuzumab
Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action