Trial · NCT00724061
Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL
NCT00724061, Not applicable, Terminated, Northwestern University; results first posted 2013-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL. Trials, record NCT00724061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724061
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL
- NCT number
- NCT00724061
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 7 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Lymphoma
- Interventions
- Pegylated interferon α-2b, Psoralens with ultraviolet light A, Narrowband-ultraviolet light B
- First posted
- 2008-07-29
- Last updated
- 2018-12-12
- Results first posted
- 2013-12-02
- Limitations and caveats
Only 7 patients were enrolled before the study was terminated by the Data Monitoring Committee due to poor accrual. Accrual was limited by a worldwide psoralen shortage and well as the exclusion of patients with prior UV light exposure.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b | From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient) | Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity. |
| Primary | Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM) | During 12 weeks of dose escalation and then up to one year during maintenance therapy. | The FACT-BRM is a patient self-report tool to assess health-related quality of life measures. |
| Secondary | Number of Patients Exhibiting a Complete Response | During 12 weeks of dose escalation and then up to one year during maintenance therapy. | Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease. CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR. |
| Secondary | To Evaluate the Duration of Response | At each study visit | To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy. |
| Other | Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment | At baseline and after 2 weeks of treatment (for those patients who consented to this portion) | The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients. |
| Other | Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells | Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b | From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient) | dose limiting toxicities | NUMBER | |
| PRIMARY | Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM) | During 12 weeks of dose escalation and then up to one year during maintenance therapy. | No data collected for this outcome measure. | ||
| SECONDARY | Number of Patients Exhibiting a Complete Response | During 12 weeks of dose escalation and then up to one year during maintenance therapy. | No data collected for this outcome measure. | ||
| SECONDARY | To Evaluate the Duration of Response | At each study visit | No data collected for this outcome measure. | ||
| OTHER_PRE_SPECIFIED | Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment | At baseline and after 2 weeks of treatment (for those patients who consented to this portion) | |||
| OTHER_PRE_SPECIFIED | Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells | Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase |
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 |
|---|---|---|---|---|---|
| Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b | PEG-IFN-alpha-2b + UV Therapy | 0 | dose limiting toxicities |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Phase | STARTED | PEG-IFN-alpha-2b + UV Therapy | 7 | |
| Dose Escalation Phase | COMPLETED | PEG-IFN-alpha-2b + UV Therapy | 2 | |
| Dose Escalation Phase | NOT COMPLETED | PEG-IFN-alpha-2b + UV Therapy | 5 | |
| Maintenance Therapy | STARTED | PEG-IFN-alpha-2b + UV Therapy | 2 | |
| Maintenance Therapy | COMPLETED | PEG-IFN-alpha-2b + UV Therapy | 2 | |
| Maintenance Therapy | NOT COMPLETED | PEG-IFN-alpha-2b + UV Therapy | 0 |
Source ClinicalTrials.gov
Adverse events35
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 | ALT, SGPT elevation | Metabolism and nutrition disorders | PEG-IFN-alpha-2b + UV Therapy | 4 | 7 | 5 |
| other | AST, SGOT elevation | Metabolism and nutrition disorders | PEG-IFN-alpha-2b + UV Therapy | 5 | 7 | 6 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | PEG-IFN-alpha-2b + UV Therapy | 3 | 7 | 7 |
| other | Anorexia | Gastrointestinal disorders | PEG-IFN-alpha-2b + UV Therapy | 1 | 7 | 1 |
| other | Burn | Skin and subcutaneous tissue disorders | PEG-IFN-alpha-2b + UV Therapy | 1 | 7 | 2 |
| other | Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | PEG-IFN-alpha-2b + UV Therapy | 1 | 7 | 1 |
| other | Constitutional symptoms - other (fever, chills, sweats, aches & pains) | General disorders | PEG-IFN-alpha-2b + UV Therapy | 2 | 7 | 3 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | PEG-IFN-alpha-2b + UV Therapy | 1 | 7 | 1 |
| other | Creatinine - elevation | Metabolism and nutrition disorders | PEG-IFN-alpha-2b + UV Therapy | 1 | 7 | 1 |
| other | Diarrhea | Gastrointestinal disorders | PEG-IFN-alpha-2b + UV Therapy | 2 | 7 | 2 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG-IFN-alpha-2b + UV Therapy | ||
| Total, other adverse events | PEG-IFN-alpha-2b + UV Therapy | 7 | 7 |
| Total, serious adverse events | PEG-IFN-alpha-2b + UV Therapy | 2 | 7 |
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 |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 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/NCT00724061
GET https://conductscience.org/api/trials/v1/NCT00724061/events?page=2