Hematologic Malignancy
Conditions
Brief summary
This was a long-term, continued treatment study that evaluated the long-term safety, clinical activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.
Detailed description
Study IPI-145-23 was an international, multicenter, open-label, single-arm, Phase 2 study designed to evaluate the long-term safety, clinical activity, and overall survival data of duvelisib in individuals with hematologic malignancies. Only individuals who have participated in a previous duvelisib study that were approved by the sponsor were allowed to enroll in the study. Participants in active treatment and participants in survival follow-up were allowed to rollover to this study. For participants on active treatment, participants continued the same dose from their previous duvelisib study administered twice daily for 28-day continuous cycles until disease progression or unacceptable toxicity and then followed in a survival follow-up period. For participants in survival follow-up, participants continued to be followed-up for survival in this study for the duration as outlined in their previous duvelisib study.
Interventions
DRUGDuvelisib
Administered as oral capsules
Sponsors
SecuraBio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have participated in a previous study of duvelisib, and: * Be actively receiving duvelisib monotherapy on the previous study (within 14 days of study entry) and demonstrating clinical benefit (complete response \[CR\]/ partial response \[PR\]/ stable disease \[SD\]) of continued use, or * Be in the survival follow-up phase of a previous duvelisib study * Have completed the required components of the previous study and be appropriate for enrollment into this long-term continued treatment and follow-up study, as determined by the Sponsor
Exclusion criteria
* Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment at screening * Was pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 45 months | A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | Up to 45 months | There were no formal secondary endpoints planned and captured data was based on disease response assessment and overall survival (OS) as defined in the participant's previous study. BOR was defined as the best time point response that a participant achieves during the study, with the response ranked according to the following order (from best to worst): complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), stable disease (SD). |
| Overall Survival (OS) | Up to 45 months | No formal secondary endpoints were planned for this study. OS was monitored in participants who continued to receive duvelisib treatment and/or in the long-term survival follow-up period in a previous duvelisib study and the number of participants alive at end of study were reported. Participants being followed for OS were contacted by the study site approximately every 6 months to collect survival status and data pertaining to any other alternative antineoplastic therapy. |
Countries
Italy, United States
Participant flow
Recruitment details
A total of 19 participants were enrolled in the current study from 3 previous studies: IPI-145-01(NCT01549106), IPI-145-02 (NCT01476657), and IPI-145-08 (NCT02204982).
Participants by arm
| Arm | Count |
|---|---|
| Duvelisib Oral capsules administered twice daily. Participants continued to receive the same dose level as their previous duvelisib study. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completed follow-up | 3 |
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Duvelisib |
|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 10.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 19 |
| other Total, other adverse events | 16 / 19 |
| serious Total, serious adverse events | 5 / 19 |
Outcome results
Primary
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Up to 45 months
Population: All Treated Analysis Set included all participants who received at least one dose of duvelisib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duvelisib | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 17 Participants |
Secondary
Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
There were no formal secondary endpoints planned and captured data was based on disease response assessment and overall survival (OS) as defined in the participant's previous study. BOR was defined as the best time point response that a participant achieves during the study, with the response ranked according to the following order (from best to worst): complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), stable disease (SD).
Time frame: Up to 45 months
Population: All Treated Analysis Set included all participants who received at least one dose of duvelisib and for whom a documented response was available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duvelisib | Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | PR | 5 Participants |
| Duvelisib | Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | CR/CRi | 9 Participants |
| Duvelisib | Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | SD | 1 Participants |
| Duvelisib | Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | Response not evaluable | 1 Participants |
Secondary
Overall Survival (OS)
No formal secondary endpoints were planned for this study. OS was monitored in participants who continued to receive duvelisib treatment and/or in the long-term survival follow-up period in a previous duvelisib study and the number of participants alive at end of study were reported. Participants being followed for OS were contacted by the study site approximately every 6 months to collect survival status and data pertaining to any other alternative antineoplastic therapy.
Time frame: Up to 45 months
Population: All Treated Analysis Set included all participants who received at least one dose of duvelisib.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duvelisib | Overall Survival (OS) | 14 Participants |