The primary purpose of this study is to evaluate the anti-tumor activity of oral Ixazomib as measured by overall response rate (ORR) in adult participants with relapsed and/or refractory follicular lymphoma (FL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Each 28-day treatment cycle will include oral administration of IXAZOMIB on Days 1, 8, and 15 followed by a rest period of 13 days.
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Number of Participants With Overall Response Rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using the international Working Group criteria for participants CR: disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Time frame: Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies
Lead-in Dose Finding Phase: Recommended Phase 2 Dose (RP2D)
Time frame: Baseline up to Cycle 1 Day 28
Progression Free Survival (PFS)
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death. Participants without documentation of PD will be censored at the date of last response assessment that is SD or better. Participants without response assessment will be censored at the date of first dose.
Time frame: Time from the date of first dose of study treatment to the date of first documented PD or death (approximately up to Day 802)
Phase 2: Rate of Disease Control
Rate of disease control is defined as percentage of participants who achieved a SD or better for greater than or equal to (\>=) 6 months.
Time frame: Baseline or until occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 805)
Time to Response (TTR)
TTR is defined as the time from the date of first dose of study treatment to the date of the first documentation of a PR or better response in a participant who responded.
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Houston, Texas, United States
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Wilrijk, Belgium
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
...and 4 more locations
Time frame: Time from the date of first dose of study treatment to the date of first documented PR or better response or death (approximately up to Day 802)
Duration of Response (DOR)
The DOR is defined as the time from the date of first documentation of a response to the date of first documented PD. Responders without documentation of PD will be censored at the date of last response assessment. DOR was categorized as CR+PR and CR.
Time frame: Time from the date of first documentation of a response to the date of first documented PD (approximately up to Day 802)
Phase 2: Number of Participants With Response Rates in PSMB1 Positive and PSMB1 Negative
Time frame: Baseline up to occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 802)
Number of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after last dose of study drug (approximately up to Day 832)
Lead-in Dose Finding Phase: Cmax: Maximum Observed Plasma Concentration for Ixazomib
Time frame: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Lead-in Dose Finding Phase: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Time frame: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose
Lead-in Dose Finding Phase: AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for Ixazomib
Time frame: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose