Trial · NCT07046078
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consent | Up to 42 days after informed consent | Will evaluate the proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consent. |
| Secondary | Number of patients transplanted | Up to 2 years | Will evaluate the number of patients transplanted. |
| Secondary | Time from day of consent to day of allogeneic hematopoietic cell transplant (HCT) | From day of consent to day of allogeneic hematopoietic cell transplant (HCT) | Will evaluate time from day of consent to day of allogeneic HCT. |
| Secondary | Reasons for failure to undergo allogeneic transplantation (allo-HCT) | Up to 2 years following Screening enrollment | Identified reasons for failure to undergo allogeneic transplantation (e.g., lack of suitable donor, complications of disease) will be systematically categorized and quantitatively reported. |
| Secondary | Incidence of adverse events | From start of conditioning (Day -9) to study-defined neutrophil engraftment, or adversely, to graft failure | Will evaluate the number of participants with non-hematologic adverse events ≥ grade 3. Will use the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for toxicity and adverse event reporting. |
| Secondary | Neutrophil count recovery | Day 0 to study-defined neutrophil engraftment, or adversely, to graft failure. | Will evaluate the time to neutrophil count recovery. The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500/µL. |
| Secondary | Platelet count recovery | Day 0 to study-defined platelet engraftment | Will evaluate the time to platelet count recovery. Platelet engraftment will be defined as the first of 7 days of a platelet count \> 20,000/µl without subsequent transfusions for 7 days. |
| Secondary | Incidence of severe adverse events | From start of conditioning (Day -9) to study-defined neutrophil engraftment, or adversely, to graft failure | Will evaluate the number of participants with any severe adverse event. Will use the NCI CTCAE version 5.0 for toxicity and adverse event reporting. |
| Secondary | Non-relapse mortality (NRM) | Up to day 100 after HCT | Will evaluate the number of participants experiencing NRM by day +100 after HCT. |
| Secondary | Rate of CD3 chimerism | At day 80 (+/- 7 days) | Will evaluate the rate of peripheral blood CD3 chimerism at day 80 (±7 days). Mixed or full donor chimerism will be evidence of donor engraftment. Full chimerism: \> 95% donor CD3+ T cells. Mixed chimerism: the detection of peripheral blood donor T cells (CD3+) and granulocytes (CD33+) as a proportion of the total peripheral blood T cell and granulocyte population, respectively. |
| Secondary | Rate of CD33 chimerism | At day 80 (+/- 7 days) | Will evaluate the rate of peripheral blood CD33 chimerism at day 80 (±7 days). Mixed or full donor chimerism will be evidence of donor engraftment. Full chimerism: \> 95% donor CD3+ T cells. Mixed chimerism: the detection of peripheral blood donor T cells (CD3+) and granulocytes (CD33+) as a proportion of the total peripheral blood T cell and granulocyte population, respectively. |
| Secondary | Incidence of acute graft versus host disease (GVHD) | Up to day 100 | Will evaluate the cumulative incidence of grade 2-4 acute GVHD by day +100. |
| Secondary | Incidence of chronic GVHD | Up to day 365 | Will evaluate the cumulative incidence of chronic GVHD requiring systemic immunosuppressive therapy by day +365. |
| Secondary | Number of participants achieving complete remission or complete remission with incomplete hematologic recovery by day +42 | Up to day 42 | Will evaluate the number of participants achieving complete remission or complete remission with incomplete hematologic recovery by day +42. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to the 2022 European LeukemiaNet criteria. |
| Secondary | Measurable ("minimal") residual disease (MRD)-negativity | Up to day 42 | Will evaluate the number of participants achieving MRD-negativity by day +42. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to the 2022 European LeukemiaNet criteria. |
| Secondary | Relapse-free survival | At day 180 | Will evaluate relapse-free survival at day +180. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to the 2022 European LeukemiaNet criteria. |
| Secondary | Overall survival | At day 180 | Will evaluate overall survival at day +180. |
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.
For software
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