TriangleNCT02663518 · OUTCOME
Parts 2 and 3: Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
What was measured
PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.
Analysis population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 2: Aggressive B-cell Lymphoma (ABCL)
Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
Part 2: Acute Myeloid Leukemia (AML)
Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.
Part 2: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines Chronic lymphocytic leukemia (CLL) Participants with (CLL) NOTE: An Arm/Group Description is shorter than the Arm/Group Title. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.
Part 2: Hodgkin Lymphoma (HL)
Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
Part 2: Indolent B-cell Lymphoma (IBCL)
Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
Part 2: Myelodysplastic Syndrome (MDS)
Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
Part 2: Multiple Myeloma (MM)
Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.
Part 2: Myeloproliferative Neoplasms (MPN)
Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Part 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Part 2: Small Cell Lung Cancer (SCLC)
Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)
Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.
| Group | Source count |
|---|---|
| Part 2: Aggressive B-cell Lymphoma (ABCL) | 3 |
| Part 2: Acute Myeloid Leukemia (AML) | 17 |
| Part 2: Chronic Lymphocytic Leukemia (CLL) | 2 |
| Part 2: Hodgkin Lymphoma (HL) | 9 |
| Part 2: Indolent B-cell Lymphoma (IBCL) | 3 |
| Part 2: Myelodysplastic Syndrome (MDS) | 5 |
| Part 2: Multiple Myeloma (MM) | 8 |
| Part 2: Myeloproliferative Neoplasms (MPN) | 2 |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 5 |
| Part 3: Peripheral T-cell Lymphoma (PTCL) | 14 |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 37 |
| Part 2: Small Cell Lung Cancer (SCLC) | 0 |
| Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL) | 9 |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Aggressive B-cell Lymphoma (ABCL) | 1.6 | Not reported | 0.7 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 2: Acute Myeloid Leukemia (AML) | 0.8 | Not reported | 0.7 | 1.0 | Not reported |
| Part 2: Chronic Lymphocytic Leukemia (CLL) | 1.4 | Not reported | 0.8 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 2: Hodgkin Lymphoma (HL) | 3.1 | Not reported | 1.0 | 4.4 | Not reported |
| Part 2: Indolent B-cell Lymphoma (IBCL) | 1.4 | Not reported | 0.7 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 2: Myelodysplastic Syndrome (MDS) | 0.8 | Not reported | 0.7 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 2: Multiple Myeloma (MM) | 1.1 | Not reported | 0.7 | 1.3 | Not reported |
| Part 2: Myeloproliferative Neoplasms (MPN) | 11.0 | Not reported | 5.6 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 3.5 | Not reported | 0.7 | NA | Upper limit of 95% CI could not be estimated due to less number of participants with events. |
| Part 3: Peripheral T-cell Lymphoma (PTCL) | 1.7 | Not reported | 1.5 | 3.1 | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 1.7 | Not reported | 1.5 | 2.3 | Not reported |
| Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL) | 5.4 | Not reported | 1.9 | 10.8 | Not reported |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 2.6 | Not reported | 1.6 | 15.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 1.6
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 1.0
- value
- 0.8
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- NA
- value
- 1.4
- group Id
- OG003
- lower Limit
- 1.0
- upper Limit
- 4.4
- value
- 3.1
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG004
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 1.4
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG005
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 0.8
- group Id
- OG006
- lower Limit
- 0.7
- upper Limit
- 1.3
- value
- 1.1
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG007
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 11.0
- comment
- Upper limit of 95% CI could not be estimated due to less number of participants with events.
- group Id
- OG008
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 3.5
- group Id
- OG009
- lower Limit
- 1.5
- upper Limit
- 3.1
- value
- 1.7
- group Id
- OG010
- lower Limit
- 1.5
- upper Limit
- 2.3
- value
- 1.7
- group Id
- OG012
- lower Limit
- 1.9
- upper Limit
- 10.8
- value
- 5.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 14
- group Id
- OG010
- value
- 37
- group Id
- OG011
- value
- 0
- units
- Participants
- description
- PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
- id
- OG000
- title
- Part 2: Aggressive B-cell Lymphoma (ABCL)
- description
- Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.
- id
- OG001
- title
- Part 2: Acute Myeloid Leukemia (AML)
- description
- Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines Chronic lymphocytic leukemia (CLL) Participants with (CLL) NOTE: An Arm/Group Description is shorter than the Arm/Group Title. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.
- id
- OG002
- title
- Part 2: Chronic Lymphocytic Leukemia (CLL)
- description
- Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
- id
- OG003
- title
- Part 2: Hodgkin Lymphoma (HL)
- description
- Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
- id
- OG004
- title
- Part 2: Indolent B-cell Lymphoma (IBCL)
- description
- Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
- id
- OG005
- title
- Part 2: Myelodysplastic Syndrome (MDS)
- description
- Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.
- id
- OG006
- title
- Part 2: Multiple Myeloma (MM)
- description
- Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.
- id
- OG007
- title
- Part 2: Myeloproliferative Neoplasms (MPN)
- description
- Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG008
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
- description
- Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.
- id
- OG009
- title
- Part 3: Peripheral T-cell Lymphoma (PTCL)
- description
- Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG010
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
- description
- Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.
- id
- OG011
- title
- Part 2: Small Cell Lung Cancer (SCLC)
- param Type
- MEDIAN
- population Description
- Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
- title
- Parts 2 and 3: Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice