Trial · NCT02763384
BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
NCT02763384, Phase 2, Terminated, Washington University School of Medicine; results first posted 2023-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma. Trials, record NCT02763384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02763384
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
- NCT number
- NCT02763384
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- T-Acute Lymphoblastic Leukemia, Adult T Lymphoblastic Lymphoma
- Interventions
- BL-8040, Nelarabine
- First posted
- 2016-05-05
- Last updated
- 2023-10-31
- Results first posted
- 2023-10-31
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days) | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting. |
| Secondary | Composite Complete Remission Rate (CRc=CR+CRi) | Completion of treatment (approximately 12 weeks) | Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3) -Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL |
| Secondary | Overall Response Rate (CR, CRi + PR) | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | * Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3) * Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL * Partial remission (PR)=A PR requires all of the CR criteria except that marrow may still contain 5-25% leukemia blast cells. An absolute neutrophil count (segs and bands) ≥ 1000/mcL, no circulating blasts, and platelets \> 100,000/mcL are requires as for a CR. For patients with measurable disease, a reduction of 50% or more in the sum of the products of the perpendicular diameters of all measurable lesions compared with pretreatment measurements and with no new or enlarging lesions |
| Secondary | Time to Response | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | * Response is CR or CRi * Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3) * Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL |
| Secondary | Duration of Response | Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment) | Defined as the interval from the date CR/CRi is documented to the date of recurrence or completion of follow-up if recurrence has not occurred. |
| Secondary | Event-free Survival (EFS) | Through completion of follow-up (maximum of 2 years after completion of treatment) | EFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, of death due to any cause. |
| Secondary | Overall Survival | Through completion of follow-up (maximum of 2 years after completion of treatment) | Defined as the date of first dose of study drug to the date of death from any cause. |
| Secondary | Rate of Patients Who Proceed to alloHCT After Treatment | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | Estimate rate of patients who proceed to alloHCT after treatment |
| Other | Interaction of Pretreatment Disease and White Blood Cell Count on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and white blood cell count on clinical outcome |
| Other | Interaction of Pretreatment Disease and Performance Status on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and performance status on clinical outcome |
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 | Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Complete Remission Rate (CRc=CR+CRi) | Completion of treatment (approximately 12 weeks) | 2 participants were not evaluable for this outcome measure because they stopped treatment prior to disease response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (CR, CRi + PR) | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | 2 participants were not evaluable for this outcome measure because they stopped treatment prior to disease response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | days | MEDIAN | |
| SECONDARY | Duration of Response | Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment) | days | MEDIAN | |
| SECONDARY | Event-free Survival (EFS) | Through completion of follow-up (maximum of 2 years after completion of treatment) | days | MEDIAN | |
| SECONDARY | Overall Survival | Through completion of follow-up (maximum of 2 years after completion of treatment) | days | MEDIAN | |
| SECONDARY | Rate of Patients Who Proceed to alloHCT After Treatment | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Interaction of Pretreatment Disease and White Blood Cell Count on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | |||
| OTHER_PRE_SPECIFIED | Interaction of Pretreatment Disease and Performance Status on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 3-5 white blood cell increased post BL-8040 injection | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 lymphadenopathy worsening | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 3-5 leukocytosis | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 infarct | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 chest pain - cardiac | 2 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 pericardial effusion | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 sinus bradycardia | 2 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 sinus tachycardia | 3 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 1-2 tinnitus | 1 | Participants | |
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | Arm 1: BL-8040 and Nelarabine | Grade 3-5 abdominal pain at study drug injection site | 1 | Participants |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: BL-8040 and Nelarabine | 12 | |
| Overall Study | COMPLETED | Arm 1: BL-8040 and Nelarabine | 10 | |
| Overall Study | NOT COMPLETED | Arm 1: BL-8040 and Nelarabine | 2 |
Source ClinicalTrials.gov
Adverse events113
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 | Lymphadenopathy worsening | Blood and lymphatic system disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 | |
| other | Chest pain - cardiac | Cardiac disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 | |
| other | Infarct | Cardiac disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 | |
| other | Pericardial effusion | Cardiac disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 | |
| other | Sinus bradycardia | Cardiac disorders | Arm 1: BL-8040 and Nelarabine | 2 | 12 | |
| other | Sinus tachycardia | Cardiac disorders | Arm 1: BL-8040 and Nelarabine | 3 | 12 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 | |
| other | Constipation | Gastrointestinal disorders | Arm 1: BL-8040 and Nelarabine | 2 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1: BL-8040 and Nelarabine | 3 | 12 | |
| other | Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Arm 1: BL-8040 and Nelarabine | 1 | 12 |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: BL-8040 and Nelarabine | 9 | 12 |
| Total, other adverse events | Arm 1: BL-8040 and Nelarabine | 12 | 12 |
| Total, serious adverse events | Arm 1: BL-8040 and Nelarabine | 8 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50CA171963 | Specialized Program of Research Excellence (SPORE) in Leukemia | LINK, DANIEL C | WASHINGTON UNIVERSITY | NATIONAL CANCER INSTITUTE | 2013 to 2025 |
Source NIH RePORTER
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.
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