B-Cell Lymphoma, T-Cell Lymphoma
Conditions
Brief summary
In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: * T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) * Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma * Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.
Interventions
1125 mg loading dose then 500 mg, oral, daily until progressive disease
Sponsors
Study design
Eligibility
Inclusion criteria
* Have measurable lesions * Have recovered from prior chemotherapies * Have an estimated life expectancy of at least 12 weeks * Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present) * Renal: serum creatinine less than or equal to 1.5XULN * Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria: * Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). * Anti-lymphoma therapy within the past 3 weeks * Unable to swallow tablets * Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Baseline to Measured Progressive Disease (Up to 114 Months) | Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months) | Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. |
| Time to Progressive (TTP) Disease | Baseline to Measured Progressive Disease (Up to 114 Months) | TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy. |
| Duration of Response (DOR) | Baseline to Measured Progressive Disease (Up to 97 Months) | DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy. |
| Percentage of Participants With Progression Free Survival (PFS) at 1-Year | Baseline to Measured Progressive Disease or Death From Any Cause (1 Year) | PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. |
| Number of Participants With One or More Drug-Related Adverse Events | Baseline to End of Study (Up to 114 Months) | Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
Countries
Australia, Brazil, Mexico, Peru, United States
Participant flow
Pre-assignment details
Completers include participants who had progressive disease, died due to any cause or alive and on study at the end of study, but off treatment.
Participants by arm
| Arm | Count |
|---|---|
| T-Cell T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. | 23 |
| Indolent B-Cell Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. | 19 |
| Aggressive B-Cell Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. | 15 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 2 | 1 |
| Overall Study | Sponsor Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | T-Cell | Indolent B-Cell | Aggressive B-Cell | Total |
|---|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 17.54 | 69.7 years STANDARD_DEVIATION 10.46 | 60.1 years STANDARD_DEVIATION 8.44 | 58.9 years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 8 Participants | 11 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 11 Participants | 4 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 2 Participants | 2 Participants | 16 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 12 Participants | 38 Participants |
| Region of Enrollment Argentina | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Australia | 1 Participants | 9 Participants | 2 Participants | 12 Participants |
| Region of Enrollment Brazil | 7 Participants | 2 Participants | 3 Participants | 12 Participants |
| Region of Enrollment Mexico | 9 Participants | 6 Participants | 7 Participants | 22 Participants |
| Region of Enrollment Peru | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 8 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 23 | 17 / 19 | 10 / 15 |
| serious Total, serious adverse events | 9 / 23 | 11 / 19 | 5 / 15 |
Outcome results
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).
Time frame: Baseline to Measured Progressive Disease (Up to 114 Months)
Population: All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 16.7 percentage of participants |
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 33.3 percentage of participants |
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 0 percentage of participants |
| Peripheral T-cell Lymphoma (PTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 50.0 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 36.4 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 9.1 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 9.1 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 36.4 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 9.1 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 0 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 14.3 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 0 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 85.7 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 12.5 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 12.5 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 62.5 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 12.5 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 100.0 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 0 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 0 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 0 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 20.0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 20.0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 40.0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 20.0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | PR | 0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CRu | 0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Unknown | 10.0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Stable Disease | 50.0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Progressive Disease (PD) | 30.0 percentage of participants |
| History of IBCL (ABCL) | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | CR | 10.0 percentage of participants |
Duration of Response (DOR)
DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy.
Time frame: Baseline to Measured Progressive Disease (Up to 97 Months)
Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable DOR data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Duration of Response (DOR) | 0 Days |
| Cutaneous T-cell Lymphoma (CTCL) | Duration of Response (DOR) | 394.0 Days |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Duration of Response (DOR) | 281.0 Days |
| Follicular Grade 1 & 2 (IBCL) | Duration of Response (DOR) | 1.0 Days |
| Marginal Zone Lymphoma (IBCL) | Duration of Response (DOR) | 0 Days |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Duration of Response (DOR) | 58.0 Days |
| History of IBCL (ABCL) | Duration of Response (DOR) | 2957.0 Days |
Number of Participants With One or More Drug-Related Adverse Events
Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Time frame: Baseline to End of Study (Up to 114 Months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Number of Participants With One or More Drug-Related Adverse Events | 2 Participants |
| Cutaneous T-cell Lymphoma (CTCL) | Number of Participants With One or More Drug-Related Adverse Events | 3 Participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Number of Participants With One or More Drug-Related Adverse Events | 0 Participants |
Percentage of Participants With Progression Free Survival (PFS) at 1-Year
PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.
Time frame: Baseline to Measured Progressive Disease or Death From Any Cause (1 Year)
Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable 1-year rate PFS data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 0.0 percentage of participants |
| Cutaneous T-cell Lymphoma (CTCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 36.8 percentage of participants |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 14.3 percentage of participants |
| Follicular Grade 1 & 2 (IBCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 51.4 percentage of participants |
| Marginal Zone Lymphoma (IBCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 0.0 percentage of participants |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 25.0 percentage of participants |
| History of IBCL (ABCL) | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | 48.6 percentage of participants |
Progression Free Survival (PFS)
Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.
Time frame: Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)
Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable PFS data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Progression Free Survival (PFS) | 58 Days |
| Cutaneous T-cell Lymphoma (CTCL) | Progression Free Survival (PFS) | 227 Days |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Progression Free Survival (PFS) | 303 Days |
| Follicular Grade 1 & 2 (IBCL) | Progression Free Survival (PFS) | 429 Days |
| Marginal Zone Lymphoma (IBCL) | Progression Free Survival (PFS) | 159 Days |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Progression Free Survival (PFS) | 114 Days |
| History of IBCL (ABCL) | Progression Free Survival (PFS) | 68 Days |
Time to Progressive (TTP) Disease
TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy.
Time frame: Baseline to Measured Progressive Disease (Up to 114 Months)
Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable TTP data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Time to Progressive (TTP) Disease | 58 Days |
| Cutaneous T-cell Lymphoma (CTCL) | Time to Progressive (TTP) Disease | 227 Days |
| Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Time to Progressive (TTP) Disease | 308 Days |
| Follicular Grade 1 & 2 (IBCL) | Time to Progressive (TTP) Disease | 429 Days |
| Marginal Zone Lymphoma (IBCL) | Time to Progressive (TTP) Disease | 159 Days |
| Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Time to Progressive (TTP) Disease | 114 Days |
| History of IBCL (ABCL) | Time to Progressive (TTP) Disease | 68 Days |