TriangleNCT03860844 · OUTCOME
Number of Participants With Negative Minimal Residual Disease (MRD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From screening until the study completion date, approximately 45 months
What was measured
MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD.
Analysis population: The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants who achieved CR/CRi were analyzed.
Groups in this outcome
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
T-cell Acute Lymphoblastic Leukemia (T-ALL)
Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
Acute Myeloid Leukemia (AML)
Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
| Group | Source count |
|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 13 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 5 |
| Acute Myeloid Leukemia (AML) | 14 |
Reported measurements
Blood, 10^-6
| Group | Source count |
|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 13 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 5 |
| Acute Myeloid Leukemia (AML) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 3 | Not reported | Not reported | Not reported | Not reported |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 1 | Not reported | Not reported | Not reported | Not reported |
Bone marrow, 10^-6
| Group | Source count |
|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 13 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 5 |
| Acute Myeloid Leukemia (AML) | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 0 | Not reported | Not reported | Not reported | Not reported |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 2 | Not reported | Not reported | Not reported | Not reported |
| Acute Myeloid Leukemia (AML) | 0 | Not reported | Not reported | Not reported | Not reported |
Bone marrow, 10^-3
| Group | Source count |
|---|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 0 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 0 |
| Acute Myeloid Leukemia (AML) | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Acute Myeloid Leukemia (AML) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Blood, 10^-6
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Bone marrow, 10^-6
- categories
- measurements
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Bone marrow, 10^-3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD.
- groups
- description
- Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
- id
- OG000
- title
- B-cell Acute Lymphoblastic Leukemia (B-ALL)
- description
- Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
- id
- OG001
- title
- T-cell Acute Lymphoblastic Leukemia (T-ALL)
- description
- Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
- id
- OG002
- title
- Acute Myeloid Leukemia (AML)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants who achieved CR/CRi were analyzed.
- reporting Status
- POSTED
- time Frame
- From screening until the study completion date, approximately 45 months
- title
- Number of Participants With Negative Minimal Residual Disease (MRD)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice