Trial · NCT02999633
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
NCT02999633, Phase 2, Terminated, Sanofi; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia. Trials, record NCT02999633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02999633
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
- NCT number
- NCT02999633
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
- Interventions
- Isatuximab SAR650984, dexamethasone, dexamethasone, acetaminophen, ranitidine, diphenhydramine
- First posted
- 2016-12-21
- Last updated
- 2022-03-21
- Other registries' IDs
- eudract:2016-002739-14
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response | Baseline until disease progression or death (maximum duration: 12.1 weeks) | Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC. |
| Secondary | Duration of Response (DOR) | Baseline until disease progression or death (maximum duration: 12.1 weeks) | DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. Progressive disease as per NCCN guidelines was defined as increase of at least 25 percentage (%) in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. |
| Secondary | Progression Free Survival (PFS) | Baseline until disease progression or death (maximum duration: 12.1 weeks) | PFS was defined as the time interval (in days) from the date of first study drug administration to the date of first observation of PD or death due to any cause, whichever came first. PD as per NCCN guidelines was defined as increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. |
| Secondary | Overall Survival (OS) | Baseline until death (maximum duration: 12.1 weeks) | Overall Survival was defined as the time interval from the date of first study drug administration to the date of death due to any cause. |
| Secondary | Number of Participants With Minimal Residual Disease (MRD) | Baseline until death or study cut-off (maximum duration: 12.1 weeks) | Presence of MRD was measured by sequencing and/or flow cytometry in participants achieving CR and CRi. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, ANC greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. Complete response with incomplete blood count recovery meet all criteria for complete response except platelet count and/or ANC. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response | Baseline until disease progression or death (maximum duration: 12.1 weeks) | Safety analysis set included all participants who received at least 1 dose of isatuximab. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Baseline until disease progression or death (maximum duration: 12.1 weeks) | The outcome measure was not analyzed due to lack of objective response. There was no specific additional data collected for the analysis of DOR as this outcome measure was to be derived using time point responses and death information that were collected and analyzed as part of primary and safety outcome measures, respectively. | ||
| SECONDARY | Progression Free Survival (PFS) | Baseline until disease progression or death (maximum duration: 12.1 weeks) | This outcome measure was not analyzed because disease progression data were not collected. | ||
| SECONDARY | Overall Survival (OS) | Baseline until death (maximum duration: 12.1 weeks) | This outcome measure was not analyzed because overall survival data were not collected. | ||
| SECONDARY | Number of Participants With Minimal Residual Disease (MRD) | Baseline until death or study cut-off (maximum duration: 12.1 weeks) | Data for this outcome measure was not collected and analyzed because no participant achieved CR or CRi. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response | Isatuximab | 0 | 95% Confidence Interval 0 to 23.2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isatuximab | 14 | |
| Overall Study | COMPLETED | Isatuximab | 0 | |
| Overall Study | NOT COMPLETED | Isatuximab | 14 |
Source ClinicalTrials.gov
Adverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Isatuximab | 1 | 14 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Isatuximab | 1 | 14 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Isatuximab | 1 | 14 | 2 |
| other | Tachycardia | Cardiac disorders | Isatuximab | 2 | 14 | 2 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Isatuximab | 1 | 14 | 1 |
| other | Constipation | Gastrointestinal disorders | Isatuximab | 2 | 14 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Isatuximab | 2 | 14 | 2 |
| other | Nausea | Gastrointestinal disorders | Isatuximab | 1 | 14 | 1 |
| other | Vomiting | Gastrointestinal disorders | Isatuximab | 1 | 14 | 1 |
| other | Asthenia | General disorders | Isatuximab | 1 | 14 | 1 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isatuximab | 6 | 14 |
| Total, other adverse events | Isatuximab | 12 | 14 |
| Total, serious adverse events | Isatuximab | 10 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02999633
GET https://conductscience.org/api/trials/v1/NCT02999633/events?page=2