Trial Outcomes & Findings for Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma (NCT NCT03890289)
NCT ID: NCT03890289
Last Updated: 2024-11-21
Results Overview
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.
TERMINATED
PHASE2
5 participants
Six months after the start of treatment
2024-11-21
Participant Flow
Participant milestones
| Measure |
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ann Arbor Stage
Stage I-II
|
0 units on a scale
n=5 Participants
|
|
Ann Arbor Stage
Stage III-IV
|
5 units on a scale
n=5 Participants
|
|
ECOG Performance Status
ECOG 0-1
|
5 units on a scale
n=5 Participants
|
|
ECOG Performance Status
ECOG >1
|
0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Six months after the start of treatmentInvestigator'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.
Outcome measures
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Primary Endpoint - Overall Response Rate (ORR)
ORR (CR+PR)
|
3 Participants
|
|
Primary Endpoint - Overall Response Rate (ORR)
SD/PD
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months from the start of treatmentOverall survival (OS) rate, measured from the date of starting therapy to the date of death from any cause. Patients alive and patients who are lost to follow up at the time of the final analysis will be censored at the date of the last contact.
Outcome measures
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Secondary Endpoints 1 - Overall Survival (OS) Rate
Alive when stopped the study
|
4 Participants
|
|
Secondary Endpoints 1 - Overall Survival (OS) Rate
Death
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months from the start of treatmentProgression-free survival (PFS) rate: measured from the date of starting therapy to the date of disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date. Patients who will have no tumor assessment after the start of therapy due to interruption of both drugs will be considered failures at the date of treatment interruption in the PFS analysis
Outcome measures
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Secondary Endpoints 2 - Progression-free Survival (PFS) Rate
Progression or death any cause when stop the study
|
3 Participants
|
|
Secondary Endpoints 2 - Progression-free Survival (PFS) Rate
No events when stop the study
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months from the start of treatmentpatients' 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
Outcome measures
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Secondary Endpoints 3 - Patients' Withdrawal Rate
Early withdrawal along induction
|
4 Participants
|
|
Secondary Endpoints 3 - Patients' Withdrawal Rate
Not wthdrawed in induction
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Six months from start of treatmentPopulation: Safety monitoring analysis
In order to monitor the safety of the treatment in small cohorts of patients, the Bayesian approach of Thall, et al. for monitoring toxicity will be used. We have planned the monitoring of toxicity to ensure that the proportion of patients with non-hematological toxicity defined as any non-hematological toxicity of grade 3 or higher after 3 and 6 cycles of induction was not higher than an acceptable level of 25%. The prior probability of toxicity (25%) is modeled by a beta distribution \[Beta (0.5,1.5)\].
Outcome measures
| Measure |
Idelalisib Plus Obinutuzumab
n=5 Participants
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
Safety Monitoring
No relevant toxicity
|
2 Participants
|
|
Safety Monitoring
Relevant toxicity
|
3 Participants
|
Adverse Events
Idelalisib Plus Obinutuzumab
Serious adverse events
| Measure |
Idelalisib Plus Obinutuzumab
n=5 participants at risk
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
General disorders
Pyrexia, respiratory failure, cough
|
20.0%
1/5 • Number of events 2 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
General disorders
Pyrexia, diarrhea, Cytomegalovirus reativation
|
20.0%
1/5 • Number of events 1 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
Other adverse events
| Measure |
Idelalisib Plus Obinutuzumab
n=5 participants at risk
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)
Idelalisib: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
Obinutuzumab: Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
|
|---|---|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 3 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
40.0%
2/5 • Number of events 2 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
General disorders
Cough
|
60.0%
3/5 • Number of events 3 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Gastrointestinal disorders
Transaminasis
|
80.0%
4/5 • Number of events 4 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
2/5 • Number of events 2 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Infections and infestations
Sars-COV-2
|
20.0%
1/5 • Number of events 1 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Infections and infestations
CMV reativation
|
20.0%
1/5 • Number of events 1 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Recorded from first dose of study drug through 30 days after the last dose of treatment: about 2.5 years
|
Additional Information
Lisa Argnani
Policlinico S.Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place