Trial · NCT06799195
Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
NCT06799195, Phase 2, Recruiting, University of Nebraska
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation. Trials, record NCT06799195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06799195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
- NCT number
- NCT06799195
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 126 participants, estimated
- Lead sponsor
- University of Nebraska
- Conditions
- Hematological Malignancies, Graft-versus-Host Disease (GVHD)
- Interventions
- Attenuated-dose Cyclophosphamide, High-dose Cyclophosphamide, Sirolimus, Mycophenolate Mofetil (MMF)
- First posted
- 2025-01-29
- Last updated
- 2026-10-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplantation | Baseline and 3 months post-transplant | The health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) trial outcome index (TOI). The FACT-BMT is a validated, patient-reported questionnaire that measures physical and functional well-being specifically in bone marrow transplant recipients. Higher scores indicate better quality of life. The primary outcome is to compare the FACT-BMT TOI scores between the attenuated-dose PTCy arm and the high-dose PTCy arm at 3 months post-transplant. |
| Secondary | Change in Karnofsky Performance Scale | Baseline and 3 months post-transplant | Karnofsky Performance Scale (KPS) is a validated tool ranging from 0 (death) to 100 (normal activity). Higher scores indicate better functional status. |
| Secondary | Change in Activities of Daily Living | Baseline and 3 months post-transplant | Activities of Daily Living (ADL) measures basic self-care tasks such as bathing and dressing. The typical total score ranges from 0 to 6, with higher scores indicating better functional status. |
| Secondary | Change in Instrumental Activities of Daily Living | Baseline and 3 months post-transplant | Change in Instrumental Activities of Daily Living (IADL) assesses more complex tasks (e.g., handling finances). Total scores typically range from 0 to 8 or 0 to 14 (depending on the version), with higher scores indicating greater independence. |
| Secondary | Change in Fried Frailty Index | Baseline and 3 months post-transplant | The Fried Frailty Index assesses five components (weight loss, exhaustion, grip strength, walking speed, and physical activity). A higher total score indicates greater frailty. |
| Secondary | Change in Clock-in-the-Box Test | Baseline and 3 months post-transplant | This is a brief test of visuospatial and executive function, typically scored on accuracy of clock drawing/placement (range 0-8). Higher scores suggest better cognitive performance. |
| Secondary | Change in History of Falls | Baseline and 3 months post-transplant | The number of falls, if any, will be collected since baseline. Results will be analyzed as the proportion of participants experiencing ≥1 fall over the time frame, or as the difference in mean (or median) number of falls between arms. |
| Secondary | Change in Body Mass Index | Baseline and 3 months post-transplant | Body Mass Index (BMI) is calculated as weight (kg) / \[height (m)\]² (kg/m²). Higher or lower values do not necessarily indicate "better" or "worse" status by themselves but will be compared between arms for changes from baseline. |
| Secondary | Change in Geriatric Depression Scale-15 | Baseline and 3 months post-transplant | The Geriatric Depression Scale-15 (GDS-15) is a 15-item screening tool for depression in older adults (scores 0-15). Higher scores indicate more severe depression. |
| Secondary | Gaft-Versus-Host Disease-Free, Relapse-Free Survival | From date of transplant to 1 year post-transplant | Graft-Versus-Host Disease (GRFS) is defined as the time from transplant to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death from any cause. An event is counted when any of these conditions are met. The GRFS at 1 year post-transplant will be compared between the two treatment arms. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Clock Drawing Task | Secondary outcome |
Source ConductCognition
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/NCT06799195
GET https://conductscience.org/api/trials/v1/NCT06799195/registered