Trial · NCT05443425
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
NCT05443425, Phase 1, Recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies. Trials, record NCT05443425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05443425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
- NCT number
- NCT05443425
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Acute Graft Versus Host Disease, Hematopoietic and Lymphoid System Neoplasm
- Interventions
- Cholestyramine, Leflunomide, Steroid Therapy
- First posted
- 2022-07-05
- Last updated
- 2026-07-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events | Up to 6 months | Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0. Unacceptable toxicity (UT) evaluation period will be from starting first loading dose of leflunomide to occurrence of UTs, or stopping leflunomide due to graft versus host disease (GVHD) progression, or day +28, whichever comes first. |
| Secondary | Overall response rate | At 28 days | Patients who have partial or complete response will be counted as responders. Patients who have stable or progressive disease or withdraw the study early before response assessment is completed will be counted as non-responders. |
| Secondary | Total steroids and length of therapy | Up to 6 months | Area under curve will be recorded. |
| Secondary | Non-relapse mortality (NRM) | At day 180 | Will be calculated from day 0 to date of non-disease death from causes other than relapse or progression. Disease relapse/progression will be counted as a competing risk. NRM will be censored at the last follow-up date if patients are alive and free of disease relapse/progression. |
| Secondary | Failure-free survival (FFS) | From day 0 to GVHD progression, disease relapse, starting new GVHD therapy, death regardless of cause, whichever comes first, assessed up to 6 months | FFS will be censored on the last follow-up if patient is still alive and free of any event of interest. |
| Secondary | Overall survival (OS) | From day 0 to date of death regardless of cause, assessed up to 1 year | |
| Secondary | Progression-free survival (PFS) | From day 0 to date of disease relapse/progression, or death regardless of cause, whichever comes first, assessed up to 1 year | PFS will be censored on the last disease assessment date if patient is still alive and disease relapse/progression is not observed. |
| Secondary | Incidence of bloodstream infections | Up to 6 months | The rate of bloodstream infections will be evaluated during leflunomide administration. |
| Secondary | Incidence of bloodstream infection severity | Up to 6 months | The severity of infections will be evaluated during leflunomide administration. |
Source ClinicalTrials.gov
Outcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT05443425
GET https://conductscience.org/api/trials/v1/NCT05443425/registered