Trial · NCT07188090
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Engraftment Syndrome | 60 days post-autologous stem cell transplant | ES will be defined as per Maiolino criteria (1) as a new fever \>100.4 F without clinical or microbiological documentation of infection plus at least 1 other criteria: (1) skin rash, (2) pulmonary infiltrates in the absence of cardiac failure, pulmonary embolism, or infection, or (3) 2 or more episodes of diarrhea a day. Clinical signs of ES have to occur within 24 hours before or after the first appearance of neutrophils in the peripheral blood. |
| Secondary | Efficacy of Stem Cell Mobilization | 30 days post-autologous stem cell transplant | To determine if G-CSF alone can successfully mobilize a sufficient number of CD34+ stem cells (approximately 3 x 106 cells/kg) in patients undergoing autologous stem cell transplantation, with Plerixafor used only when necessary. Efficacy of Stem Cell Mobilization will be analyzed using descriptive statistics and, where appropriate, survival analysis methods. |
| Secondary | Time to Neutrophil Engraftment | Up to 90 days post-transplant | To compare the time to engraftment of neutrophils and platelets in patients mobilized with G-CSF alone versus those requiring Plerixafor. Neutrophil engraftment is defined as ANC \>500 x10e9/L x 3 days, with day of engraftment the first of the 3 days of ANC \>500 x10e9/L. Platelet engraftment is defined as date platelet greater than or equal to (≥) 20 x 10e9 /L which is sustained for 3 consecutive days without a platelet transfusion within the last 7 days. Time-to-event analyses, such as Kaplan-Meier survival curves, will be used to evaluate the time to neutrophil and platelet engraftment. |
| Secondary | Time to Platelet Engraftment | Up to 90 days post-transplant | To compare the time to engraftment of neutrophils and platelets in patients mobilized with G-CSF alone versus those requiring Plerixafor. Neutrophil engraftment is defined as ANC \>500 x10e9/L x 3 days, with day of engraftment the first of the 3 days of ANC \>500 x10e9/L. Platelet engraftment is defined as date platelet greater than or equal to (≥) 20 x 10e9 /L which is sustained for 3 consecutive days without a platelet transfusion within the last 7 days. Time-to-event analyses, such as Kaplan-Meier survival curves, will be used to evaluate the time to neutrophil and platelet engraftment. |
| Secondary | Number of Collection Days | Up to 90 days post-transplant | To evaluate the average number of collection days needed to achieve the target CD34+ cell count, with and without Plerixafor. |
| Secondary | Length of Hospital Stay | Up to 90 days post-transplant | To examine whether the approach of limiting Plerixafor use influences the duration of the hospital stay for stem cell collection and transplantation. |
| Secondary | Disease Response | Up to 90 days post-transplant | To analyze the patient's response to treatment posttransplantation, including complete response, very good partial response, partial response, stable disease, or progressive disease. |
| Secondary | Cell Composition | Up to 90 days post-transplant | To investigate the composition of the collected stem cell product, particularly focusing on the percentage of CD34+ cells and other relevant immune cell populations via flow cytometry: T cell subsets (CD3+, CD4+, CD8+), B cells, natural killer (NK) cells in patients with and without Plerixafor. Cell composition data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups. |
| Secondary | Cytokine Analysis | At Baseline | To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups. |
| Secondary | Cytokine Analysis | At Day 10 | To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups. |
| Secondary | Cytokine Analysis | At Day 28 | To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups. |
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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