Trial · NCT07222579
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 | Cohort A - Overall Survival | Up to 3 years | The Overall Survival (OS) is the time from treatment initiation to death from any cause. |
| Primary | Cohort B - Rate of Complete Remission (CR), Complete Remission with Partial Hematological Recovery (CRh), or Complete Remission with Incomplete Hematological Recovery (CRi) with Minimal Residual Disease (MRD) negativity | At completion of 2 cycles (each cycle is 34 days) | The rate of achievement of complete remission (CR/CRh/CRi) with MRD-negativity (\<0.01%) after the first two cycles of therapy with blinatumomab. CR: Bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1000/µL and platelets ≥100,000/µL; MRD+ or unknown. CR +CRh: Bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥500/µL AND platelet count ≥50,000/µL. CR +CRi: Bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; with residual thrombocytopenia (platelet count of \<100,000/µL) OR residual neutropenia (ANC \<1000/µL); not fulfilling criteria for CRh. MRD Negativity: No detectable cancer cells using sensitive tests, with less than 0.01% cancer cells. MRD positivity indicates a higher risk of relapse, while MRD negativity is linked to long-term remission and survival benefits. |
| Primary | Cohort C - Rate of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh) | At completion of 2 cycles (each cycle is 34 days) | The rate of achievement of complete remission (CR/CRh) after the first two cycles of therapy with blinatumomab. Complete Remission (CR): No detectable cancer cells in the bone marrow (less than 5% blast cells) and normal blood counts. CRh: No detectable cancer cells, with partial recovery of blood counts (ANC 500-1,000/µL, platelets 50,000-100,000/µL). The rate of achieving these states is calculated by the proportion of patients who reach CR/CRh within a set time. Higher rates of achievement indicate that a larger proportion of participants are responding positively to the treatment, with no detectable cancer cells in their bone marrow and recovery of blood counts. |
| Secondary | Cohort A - MRD-negative CR + CRh rate | At completion of 2 cycles (each cycle is 34 days) | MRD-negative CR + CRh rate is the proportion of participants who achieve either Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh) and also have no detectable minimal residual disease (MRD) in bone marrow. Higher rates of MRD-negative CR + CRh indicate the treatment is highly effective in both inducing remission and reducing the risk of relapse. |
| Secondary | Cohort A - Event-Free Survival (EFS) | Up to approximately 3 years | Time from treatment initiation to the earliest occurrence of one of the following events: * Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab * Relapse after achieving CR, CRh, or CRi * Initiation of new leukemia-directed therapy due to persistent disease or progression * Death from any cause |
| Secondary | Cohort A - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
| Secondary | Cohort B - Overall Survival | Up to approximately 3 years | The Overall Survival (OS)is the time from treatment initiation to death from any cause. |
| Secondary | Cohort B - Rate of MRD-negativity (<0.01%) | At completion of 1 cycle (cycle is 34 days) | The rate of MRD-negativity (\<0.01%) within one cycle of SC-blinatumomab treatment. MRD negativity means that the number of cancer cells is below the threshold of 0.01%. A higher rate of MRD negativity suggests that the treatment is highly effective in eliminating cancer cells and reducing the risk of relapse. |
| Secondary | Cohort B - Event-Free Survival (EFS) | Up to approximately 1 year | Time from treatment initiation to the earliest occurrence of one of the following events: * Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab * Relapse after achieving CR, CRh, or CRi * Initiation of new leukemia-directed therapy due to persistent disease or progression * Death from any cause |
| Secondary | Cohort B - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
| Secondary | Cohort C - Overall Survival | Up to approximately 3 years | The Overall Survival (OS)is the time from treatment initiation to death from any cause. |
| Secondary | Cohort C - Event-Free Survival (EFS) | Up to approximately 1 year | Time from treatment initiation to the earliest occurrence of one of the following events: * Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab * Relapse after achieving CR, CRh, or CRi * Initiation of new leukemia-directed therapy due to persistent disease or progression * Death from any cause |
| Secondary | Cohort C - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
| Secondary | Overall - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). |
| Other | Overall - Characterization of Antigen Expression | Up to 10 years | Assess CD19, CD81, and CD21 expression (levels) in leukemic blasts through flow cytometry and/or immunohistochemical staining to evaluate potential biomarkers of treatment response and resistance. High expression levels may correlate with better treatment outcomes, while low or absent expression may indicate resistance. |
| Other | Overall - Frequency of Cytogenetic Abnormalities Identified by Karyotyping and Fluorescence In Situ Hybridization (FISH) | Up to approximately 10 years | Percentage of patients with identified cytogenetic abnormalities and will be correlated descriptively with clinical outcomes including treatment response, relapse, and overall survival. The frequency and pattern of disease-specific chromosomal abnormalities detected by conventional karyotyping and fluorescence in situ hybridization (FISH) in leukemic blasts. |
| Other | Overall - Frequency of Somatic Mutations Identified by Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) | Up to approximately 10 years | Percentage of patients with specific genetic alterations and explored for associations with treatment response, relapse patterns, and disease progression. The frequency and spectrum of somatic mutations, gene fusions, or rearrangements detected using next-generation sequencing (NGS) and/or polymerase chain reaction (PCR) in leukemic cells. |
| Other | Overall - Transplantation and Cellular Therapy Outcomes | Up to approximately 3 years | The proportion of subjects proceeding to allogeneic hematopoietic stem cell transplantation (alloHSCT) after SC-blinatumomab treatment, assessing their post-transplant outcomes, relapse rates, and overall survival. |
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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