Trial · NCT00007345
Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
NCT00007345, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma. Trials, record NCT00007345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00007345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
- NCT number
- NCT00007345
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cutaneous T Cell Lymphoma, Peripheral T Cell Lymphoma
- Interventions
- Romidepsin
- First posted
- 2000-12-18
- Last updated
- 2017-05-16
- Results first posted
- 2016-02-12
- Limitations and caveats
7 cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | up to 56.5 days | A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry. |
| Primary | Duration of Response (DOR) | up to 127 months | DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry. |
| Secondary | Number of Participants With Adverse Events | 147 months and 5 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Median Number of Cycles of Depsipeptide Administered | 83 cycles (i.e., each cycle is 21 days) | Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability. |
| Secondary | Time to Progression | Until disease progression, or 30 days following off study date | Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry. |
| Secondary | Fold Change in Histone Acetylation | 4 hours, 24 hours, and 48 hours after Romidepsin | Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide). |
| Secondary | Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression | 4 hours, 24 hours, and 48 hours after Romidepsin | Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | up to 56.5 days | Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment. | participants | NUMBER |
| PRIMARY | Duration of Response (DOR) | up to 127 months | Months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | 147 months and 5 days | participants | NUMBER | |
| SECONDARY | Median Number of Cycles of Depsipeptide Administered | 83 cycles (i.e., each cycle is 21 days) | Cycles per patient | MEDIAN | |
| SECONDARY | Time to Progression | Until disease progression, or 30 days following off study date | Months | MEDIAN | |
| SECONDARY | Fold Change in Histone Acetylation | 4 hours, 24 hours, and 48 hours after Romidepsin | Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value. | Fold change | MEDIAN |
| SECONDARY | Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression | 4 hours, 24 hours, and 48 hours after Romidepsin | ABCB1 expression of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value. | Fold change | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response | Peripheral T-cell Lymphoma (PTCL) | Complete Response + Partial Response | 17 | participants | |
| Number of Participants With a Response | Cutaneous T-cell Lymphoma (CTCL) | Complete Response + Partial Response | 28 | participants | |
| Number of Participants With a Response | Peripheral T-cell Lymphoma (PTCL) | Complete Response | 8 | participants | |
| Number of Participants With a Response | Cutaneous T-cell Lymphoma (CTCL) | Complete Response | 5 | participants | |
| Number of Participants With a Response | Peripheral T-cell Lymphoma (PTCL) | Partial Response | 9 | participants | |
| Number of Participants With a Response | Cutaneous T-cell Lymphoma (CTCL) | Partial Response | 23 | participants | |
| Number of Participants With a Response | Peripheral T-cell Lymphoma (PTCL) | Stable Disease | 5 | participants | |
| Number of Participants With a Response | Cutaneous T-cell Lymphoma (CTCL) | Stable Disease | 32 | participants | |
| Number of Participants With a Response | Peripheral T-cell Lymphoma (PTCL) | Progressive disease | 18 | participants | |
| Number of Participants With a Response | Cutaneous T-cell Lymphoma (CTCL) | Progressive disease | 18 | participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peripheral T-cell Lymphoma (PTCL) | 47 | |
| Overall Study | STARTED | Cutaneous T-cell Lymphoma (CTCL) | 84 | |
| Overall Study | COMPLETED | Peripheral T-cell Lymphoma (PTCL) | 45 | |
| Overall Study | COMPLETED | Cutaneous T-cell Lymphoma (CTCL) | 73 | |
| Overall Study | NOT COMPLETED | Peripheral T-cell Lymphoma (PTCL) | 2 | |
| Overall Study | NOT COMPLETED | Cutaneous T-cell Lymphoma (CTCL) | 11 |
Source ClinicalTrials.gov
Adverse events414
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 | Anemia | Blood and lymphatic system disorders | Peripheral T-cell Lymphoma (PTCL) | 38 | 47 | 151 |
| other | Anemia | Blood and lymphatic system disorders | Cutaneous T-cell Lymphoma (CTCL) | 53 | 84 | 166 |
| other | Anorexia | Gastrointestinal disorders | Peripheral T-cell Lymphoma (PTCL) | 31 | 47 | 124 |
| other | Anorexia | Gastrointestinal disorders | Cutaneous T-cell Lymphoma (CTCL) | 37 | 84 | 79 |
| other | Constipation | Gastrointestinal disorders | Peripheral T-cell Lymphoma (PTCL) | 17 | 47 | 29 |
| other | Constipation | Gastrointestinal disorders | Cutaneous T-cell Lymphoma (CTCL) | 33 | 84 | 61 |
| other | Fatigue | General disorders | Peripheral T-cell Lymphoma (PTCL) | 34 | 47 | 129 |
| other | Fatigue | General disorders | Cutaneous T-cell Lymphoma (CTCL) | 68 | 84 | 194 |
| other | Headache | Nervous system disorders | Peripheral T-cell Lymphoma (PTCL) | 17 | 47 | 32 |
| other | Headache | Nervous system disorders | Cutaneous T-cell Lymphoma (CTCL) | 18 | 84 | 33 |
1 to 10 of 414Source ClinicalTrials.gov
See all 414 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peripheral T-cell Lymphoma (PTCL) | 6 | 47 |
| Total, all-cause mortality | Cutaneous T-cell Lymphoma (CTCL) | 5 | 84 |
| Total, other adverse events | Peripheral T-cell Lymphoma (PTCL) | 47 | 47 |
| Total, other adverse events | Cutaneous T-cell Lymphoma (CTCL) | 83 | 84 |
| Total, serious adverse events | Peripheral T-cell Lymphoma (PTCL) | 20 | 47 |
| Total, serious adverse events | Cutaneous T-cell Lymphoma (CTCL) | 38 | 84 |
Source ClinicalTrials.gov
Papers10
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Peripheral T-cell Lymphoma (PTCL) vs Cutaneous T-cell Lymphoma (CTCL): deaths from any cause | Trial comparisons |
| Peripheral T-cell Lymphoma (PTCL) vs Cutaneous T-cell Lymphoma (CTCL): Number of Participants With Adverse Events | Trial comparisons |
| Peripheral T-cell Lymphoma (PTCL) vs Cutaneous T-cell Lymphoma (CTCL): serious adverse events | Trial comparisons |
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/NCT00007345
GET https://conductscience.org/api/trials/v1/NCT00007345/results?page=2