Trial · NCT00255801
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
NCT00255801, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma. Trials, record NCT00255801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00255801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
- NCT number
- NCT00255801
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Lymphoma
- Interventions
- Targretin® (bexarotene), pegylated liposomal doxorubicin hydrochloride
- First posted
- 2005-11-21
- Last updated
- 2018-08-16
- Results first posted
- 2018-08-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free Survival | 3 years | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease |
| Secondary | Maximum Therapeutic Response | 2 years | CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease |
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 | Median Progression-free Survival | 3 years | months | MEDIAN | |
| SECONDARY | Maximum Therapeutic Response | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival | Doxil and Targretin® (Bexarotene) | 5 | Full Range 0.16 to 26.26 | months | |
| Maximum Therapeutic Response | Doxil and Targretin® (Bexarotene) | Clinical Complete Response | 2 | Participants | |
| Maximum Therapeutic Response | Doxil and Targretin® (Bexarotene) | Partial Response | 12 | Participants | |
| Maximum Therapeutic Response | Doxil and Targretin® (Bexarotene) | Stable Disease | 6 | Participants | |
| Maximum Therapeutic Response | Doxil and Targretin® (Bexarotene) | Progressive Disease | 14 | Participants | |
| Maximum Therapeutic Response | Doxil and Targretin® (Bexarotene) | Not Evaluable | 3 | 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 | Doxil and Targretin® (Bexarotene) | 37 | |
| Overall Study | COMPLETED | Doxil and Targretin® (Bexarotene) | 37 | |
| Overall Study | NOT COMPLETED | Doxil and Targretin® (Bexarotene) | 0 |
Source ClinicalTrials.gov
Adverse events28
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 | Hyperglycemia | Metabolism and nutrition disorders | Doxil and Targretin® (Bexarotene) | 11 | 37 | |
| other | White blood cells | Investigations | Doxil and Targretin® (Bexarotene) | 9 | 37 | |
| other | Cholesterol, high | Investigations | Doxil and Targretin® (Bexarotene) | 7 | 37 | |
| other | Triglyceride, high | Metabolism and nutrition disorders | Doxil and Targretin® (Bexarotene) | 7 | 37 | |
| other | Fatigue | General disorders | Doxil and Targretin® (Bexarotene) | 4 | 37 | |
| other | Neutrophils | Investigations | Doxil and Targretin® (Bexarotene) | 4 | 37 | |
| other | Lymphopenia | Investigations | Doxil and Targretin® (Bexarotene) | 3 | 37 | |
| other | Pruritus/itching | Skin and subcutaneous tissue disorders | Doxil and Targretin® (Bexarotene) | 3 | 37 | |
| other | Pain - Back | Musculoskeletal and connective tissue disorders | Doxil and Targretin® (Bexarotene) | 2 | 37 | |
| other | Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | Doxil and Targretin® (Bexarotene) | 2 | 37 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxil and Targretin® (Bexarotene) | 12 | 37 |
| Total, other adverse events | Doxil and Targretin® (Bexarotene) | 37 | 37 |
| Total, serious adverse events | Doxil and Targretin® (Bexarotene) | 15 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24285015 | DERIVED |
Source PubMed
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/NCT00255801
GET https://conductscience.org/api/trials/v1/NCT00255801/events?page=2