Trial · NCT02614066
A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
NCT02614066, Phase 1, Phase 2, Completed, Kite, A Gilead Company; results first posted 2021-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3). Trials, record NCT02614066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02614066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
- NCT number
- NCT02614066
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Kite, A Gilead Company
- Conditions
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
- Interventions
- brexucabtagene autoleucel, Cyclophosphamide, Fludarabine
- First posted
- 2015-11-25
- Last updated
- 2024-11-19
- Other registries' IDs
- eudract:2015-005009-35
- Results first posted
- 2021-11-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation | DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia). |
| Primary | Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid\[CSF\]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses \>1.5 cm in greatest transverse diameter\[GTD\] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm\[long axis\] and \>1.0 cm\[short axis\] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt\<100000/μL or ANC\<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: Complete Remission (CR) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: Duration of Remission (DOR) Per Independent Review | From first CR or CRi (Phase 2) up to 3.7 years | DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with \< 5 white blood cells \[WBCs\] per mm\^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm\^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses. |
| Secondary | Phase 2: OCR Rate (CR + CRi) Per Investigator Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt \<100000/µL or ANC \<1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | |
| Secondary | Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. |
| Secondary | Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation | DLT-Evaluable Analysis Set included first 3 participants in Phase 1 treated with target brexucabtagene autoleucel dose and followed for at least 28 days. Only participants from Phase 1: 2 X 10\^6 Anti-CD19 CAR T Cells/kg were pre-specified to be assessed for this Outcome Measure. | percentage of participants | NUMBER |
| PRIMARY | Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | The modified Intent-to-Treat (mITT) Analysis Set included all enrolled participants treated with brexucabtagene autoleucel in Phase 2. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Participants in mITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Complete Remission (CR) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Participants in mITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Participants in mITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Duration of Remission (DOR) Per Independent Review | From first CR or CRi (Phase 2) up to 3.7 years | Participants in mITT Analysis Set with overall complete remission (CR or CRi ) were analyzed. | months | MEDIAN |
| SECONDARY | Phase 2: OCR Rate (CR + CRi) Per Investigator Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | Participants in mITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | Participants in mITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Participants in mITT Analysis Set with CR were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Participants in mITT Analysis Set with CRi were analyzed. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group286
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | percentage of participants | ||
| Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 70.9 | 95% Confidence Interval 57 to 82 | percentage of participants | |
| Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 76 | 95% Confidence Interval 63 to 87 | percentage of participants | |
| Phase 2: Complete Remission (CR) Rate Per Independent Review | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 56.4 | 95% Confidence Interval 42 to 70 | percentage of participants | |
| Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 14.5 | 95% Confidence Interval 6 to 27 | percentage of participants | |
| Phase 2: Duration of Remission (DOR) Per Independent Review | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 14.6 | 95% Confidence Interval 9.4 to 24.1 | months | |
| Phase 2: OCR Rate (CR + CRi) Per Investigator Review | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 72.7 | 95% Confidence Interval 59 to 84 | percentage of participants | |
| Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 20 | percentage of participants | ||
| Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 97 | 95% Confidence Interval 83 to 100 | percentage of participants | |
| Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 | 95% Confidence Interval 63 to 100 | percentage of participants |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 6 | |
| Overall Study | STARTED | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 28 | |
| Overall Study | STARTED | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 20 | |
| Overall Study | STARTED | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 71 | |
| Overall Study | COMPLETED | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | |
| Overall Study | COMPLETED | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | |
| Overall Study | COMPLETED | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | |
| Overall Study | COMPLETED | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | |
| Overall Study | NOT COMPLETED | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 6 | |
| Overall Study | NOT COMPLETED | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,096
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 | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 14 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 4 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 29 | 55 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | 6 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | 23 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 1 | 16 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 1 | 55 | |
| other | Bone marrow reticulin fibrosis | Blood and lymphatic system disorders | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 1 | 6 | |
| other | Bone marrow reticulin fibrosis | Blood and lymphatic system disorders | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 | 23 |
1 to 10 of 1,096Source ClinicalTrials.gov
See all 1,096 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 6 | 6 |
| Total, all-cause mortality | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 17 | 28 |
| Total, all-cause mortality | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 15 | 20 |
| Total, all-cause mortality | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 39 | 71 |
| Total, other adverse events | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 6 | 6 |
| Total, other adverse events | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 23 | 23 |
| Total, other adverse events | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | 16 | 16 |
| Total, other adverse events | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 55 | 55 |
| Total, serious adverse events | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 6 | 6 |
| Total, serious adverse events | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 21 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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/NCT02614066
GET https://conductscience.org/api/trials/v1/NCT02614066/results?page=2