Trial · NCT02296164
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
NCT02296164, Completed, Helsinn Therapeutics (U.S.), Inc; results first posted 2019-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma. Trials, record NCT02296164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02296164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
- NCT number
- NCT02296164
- Status
- Completed
- Enrollment
- 300 participants, actual
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Conditions
- Mycosis Fungoides
- Interventions
- Valchlor
- First posted
- 2014-11-20
- Last updated
- 2020-03-04
- Results first posted
- 2019-12-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Responders Using Body Surface Area (BSA) at 12 Months | 12 Months | The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Responders Using Body Surface Area (BSA) at 12 Months | 12 Months | The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Responders Using Body Surface Area (BSA) at 12 Months | MF-CTCL Patients Receiving Valchlor | 44 | 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 | MF-CTCL Patients Receiving Valchlor | 298 | |
| Overall Study | COMPLETED | MF-CTCL Patients Receiving Valchlor | 188 | |
| Overall Study | NOT COMPLETED | MF-CTCL Patients Receiving Valchlor | 110 |
Source ClinicalTrials.gov
Adverse events54
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 | Dermatitis | Skin and subcutaneous tissue disorders | MF-CTCL Patients Receiving Valchlor | 38 | 298 | 38 |
| other | Erythema | Skin and subcutaneous tissue disorders | MF-CTCL Patients Receiving Valchlor | 15 | 298 | 15 |
| other | Pruritus | Skin and subcutaneous tissue disorders | MF-CTCL Patients Receiving Valchlor | 29 | 298 | 29 |
| other | Skin irritation | Skin and subcutaneous tissue disorders | MF-CTCL Patients Receiving Valchlor | 22 | 298 | 22 |
| serious | Skin ulcer | Skin and subcutaneous tissue disorders | MF-CTCL Patients Receiving Valchlor | 2 | 298 | 2 |
| serious | Abdominal pain | Gastrointestinal disorders | MF-CTCL Patients Receiving Valchlor | 1 | 298 | 1 |
| serious | Asthenia | General disorders | MF-CTCL Patients Receiving Valchlor | 1 | 298 | 1 |
| serious | Death | General disorders | MF-CTCL Patients Receiving Valchlor | 2 | 298 | 2 |
| serious | Fatigue | General disorders | MF-CTCL Patients Receiving Valchlor | 1 | 298 | 1 |
| serious | Multi-organ failure | General disorders | MF-CTCL Patients Receiving Valchlor | 1 | 298 | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MF-CTCL Patients Receiving Valchlor | 0 | 298 |
| Total, other adverse events | MF-CTCL Patients Receiving Valchlor | 104 | 298 |
| Total, serious adverse events | MF-CTCL Patients Receiving Valchlor | 23 | 298 |
Source ClinicalTrials.gov
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/NCT02296164
GET https://conductscience.org/api/trials/v1/NCT02296164/events?page=2