Trial · NCT07188090
Mozobil for Autologous Hematopoietic Stem Cell Transplantation
NCT07188090, Phase 2, Recruiting, Thomas Jefferson University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mozobil for Autologous Hematopoietic Stem Cell Transplantation. Trials, record NCT07188090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07188090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mozobil for Autologous Hematopoietic Stem Cell Transplantation
- NCT number
- NCT07188090
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Multiple Myeloma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Interventions
- Plerixafor, Gcsf
- First posted
- 2025-09-23
- Last updated
- 2025-11-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT07188090
GET https://conductscience.org/api/trials/v1/NCT07188090/registered