Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma

NCT03890289 | Terminated Phase 2 Results DMC

• 1 other identifier: FIL_GAUDEALIS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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.

Conditions

Follicular Lymphoma

Keywords

Idelalisib; Obinutuzumab; Relapsed/Refractory Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint - Overall Response Rate (ORR)

  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 according with 2014 Lugano criteria.

  Six months after the start of treatment

Secondary Outcomes (3)

• Secondary Endpoints 1 - Overall Survival (OS) Rate

  Up to 24 months from the start of treatment

• Secondary Endpoints 2 - Progression-free Survival (PFS) Rate

  Up to 24 months from the start of treatment

• Secondary Endpoints 3 - Patients' Withdrawal Rate

  Up to 24 months from the start of treatment

Other Outcomes (1)

• Safety Monitoring

  Six months from start of treatment

Study Arms (1)

Idelalisib Plus Obinutuzumab

EXPERIMENTAL

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; Drug: Obinutuzumab

Interventions

Idelalisib DRUG

Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma

Idelalisib Plus Obinutuzumab

Obinutuzumab DRUG

Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma

Idelalisib Plus Obinutuzumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (4)

Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, 50141, Italy

Location

AOU Maggiore della Carità di Novara - SCDU Ematologia

Novara, 28100, Italy

Location

Azienda sanitaria-universitaria integrata Trieste (ASUITS) - SC Ematologia

Trieste, 34121, Italy

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

idelalisib; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Lisa Argnani
• Organization: Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"

lisa.argnani@unibo.it

051 214 3827

Study Officials

• Pierluigi Zinzani, Prof.

  Bologna - Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: October 18, 2019
• Primary Completion: April 29, 2021
• Study Completion: May 10, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)