Trial · NCT02763384
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 |
| Other | Interaction of Pretreatment Disease and Immunophenotype on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and immunophenotype on clinical outcome |
| Other | Interaction of Pretreatment Disease and Cytogenetics on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and cytogenetics on clinical outcome |
| Other | Interaction of Pretreatment Disease and CXCR4 Expression on Lymphoblasts on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and CXCR4 expression on lymphoblasts on clinical outcome |
| Other | Interaction of Pretreatment Disease and Morphology on Clinical Outcome | Up to 2 years after completion of treatment (approximately 116 weeks) | Interaction of pretreatment disease and morphology on clinical outcome |
| Other | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Alterations in Lymphoblast Cell Cycle Status | Completion of treatment (approximately 12 weeks) | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by alterations in lymphoblast cell cycle status |
| Other | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Induction of Apoptosis in Lymphoblasts | Completion of treatment (approximately 12 weeks) | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by induction of apoptosis in lymphoblasts |
| Other | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Mobilization of Lymphoblasts Into the Peripheral Circulation | Completion of treatment (approximately 12 weeks) | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by mobilization of lymphoblasts into the peripheral circulation |
| Other | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Inhibition of CXCR4 Signaling on Lymphoblasts | Completion of treatment (approximately 12 weeks) | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by inhibition of CXCR4 signaling on lymphoblasts |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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