Trial · NCT04463615
Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders
NCT04463615, Phase 2, Completed, City of Hope Medical Center; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders. Trials, record NCT04463615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04463615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders
- NCT number
- NCT04463615
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Recurrent Lymphoproliferative Disorder, Refractory Lymphoproliferative Disorder
- Interventions
- Leflunomide
- First posted
- 2020-07-09
- Last updated
- 2023-12-05
- Results first posted
- 2023-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. | Defined as the proportion of patients with a documented response (complete response \[CR\] or partial \[PR\]) any time during study treatment. Response will be categorized by modified severity weighted assessment tool (mSWAT). Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment. |
| Secondary | Complete Response Rate | Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and was off treatment on Day 14 of the second cycle due to disease progression. | Defined as the proportion of patients with a documented CR any time during study treatment. Response will be assessed by mSWAT. Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. | percentage of participants | NUMBER | |
| SECONDARY | Complete Response Rate | Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and was off treatment on Day 14 of the second cycle due to disease progression. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Treatment (Leflunomide) | 0 | percentage of participants | ||
| Complete Response Rate | Treatment (Leflunomide) | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Leflunomide) | 1 | |
| Overall Study | COMPLETED | Treatment (Leflunomide) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Leflunomide) | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Cholesterol high | Investigations | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Hypokalemia | Metabolism and nutrition disorders | Treatment (Leflunomide) | 1 | 1 | 2 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Dizziness | Nervous system disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Treatment (Leflunomide) | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Leflunomide) | 0 | 1 |
| Total, other adverse events | Treatment (Leflunomide) | 1 | 1 |
| Total, serious adverse events | Treatment (Leflunomide) | 0 | 1 |
Source ClinicalTrials.gov
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/NCT04463615
GET https://conductscience.org/api/trials/v1/NCT04463615/registered