Trial · NCT06923488
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
NCT06923488, Phase 1, Phase 2, Recruiting, West Virginia University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes. Trials, record NCT06923488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06923488
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
- NCT number
- NCT06923488
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- West Virginia University
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Leflunomide 10mg, Leflunomide 20mg, Decitabine
- First posted
- 2025-04-11
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of incidences of regimen limiting toxicities (RLTs) | Date of first treatment up to 13 months | Percentages of incidences of RLTs defined as: * A need to reduce the dose of one or both of the treatments * Discontinue the treatment due to dose limiting toxicities, AE/SAE * Be withheld at the discretion of the treating physician and on the basis of the expected adverse event |
| Secondary | Percentage of Complete Remission (CR) Rate (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | Percentage of Complete Remission (CR) Rate (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | Percentage of Complete Remission (CR) Rate (12th cycle) | Within 30 days of the end of the 12th cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (12th cycle) | Within 30 days following the end of the 12th cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (12th cycle) | Within 30 days following the end of the 12th cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
Papers12
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.
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/NCT06923488
GET https://conductscience.org/api/trials/v1/NCT06923488/registered