Trial · NCT00426764
A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
NCT00426764, Phase 2, Completed, Celgene; results first posted 2012-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma. Trials, record NCT00426764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00426764
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
- NCT number
- NCT00426764
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Romidepsin
- First posted
- 2007-01-25
- Last updated
- 2020-02-11
- Other registries' IDs
- eudract:2006-006228-21
- Results first posted
- 2012-08-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by \>75% in their SPD. |
| Secondary | Percentage of Participants With Objective Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response (PR) according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses \& extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%. |
| Secondary | Duration of Objective Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions. |
| Secondary | Duration of Complete Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions. |
| Secondary | Time to Disease Progression | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates. |
| Secondary | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days. | An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study. |
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 | Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient. | days | MEDIAN |
| SECONDARY | Duration of Complete Disease Response | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient. | days | MEDIAN |
| SECONDARY | Time to Disease Progression | Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient. | days | MEDIAN |
| SECONDARY | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days. | Safety Population: all participants who received at least 1 dose of romidepsin. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days. | Safety Population: all participants who received at least 1 dose of romidepsin. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee | Romidepsin | 15.4 | 95% Confidence Interval 9.7 to 22.8 | percentage of participants | |
| Percentage of Participants With Objective Disease Response | Romidepsin | 26.2 | 95% Confidence Interval 18.8 to 34.6 | percentage of participants | |
| Duration of Objective Disease Response | Romidepsin | NA | 95% Confidence Interval 353 to NA | days | |
| Duration of Complete Disease Response | Romidepsin | NA | 95% Confidence Interval 500 to NA | days | |
| Time to Disease Progression | Romidepsin | 182 | 95% Confidence Interval 106 to 290 | days | |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Missing | Missing Baseline ECOG Score | 1 | participants | |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Best ECOG = 0 | Missing Baseline ECOG Score | 0 | participants | |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Best ECOG = 1 | Missing Baseline ECOG Score | 0 | participants | |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Best ECOG = 2 | Missing Baseline ECOG Score | 0 | participants | |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Best ECOG = 3 | Missing Baseline ECOG Score | 0 | participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Romidepsin | 131 | |
| Overall Study | Discontinued Prior to or During Cycle 6 | Romidepsin | 98 | |
| Overall Study | Discontinued at End of or After Cycle 6 | Romidepsin | 33 | |
| Overall Study | COMPLETED | Romidepsin | 0 | |
| Overall Study | NOT COMPLETED | Romidepsin | 131 |
Source ClinicalTrials.gov
Adverse events145
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 | Anaemia | Blood and lymphatic system disorders | Romidepsin | 32 | 131 | |
| other | Leukopenia | Blood and lymphatic system disorders | Romidepsin | 15 | 131 | |
| other | Neutropenia | Blood and lymphatic system disorders | Romidepsin | 37 | 131 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Romidepsin | 53 | 131 | |
| other | Tachycardia | Cardiac disorders | Romidepsin | 13 | 131 | |
| other | Abdominal pain | Gastrointestinal disorders | Romidepsin | 15 | 131 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Romidepsin | 9 | 131 | |
| other | Constipation | Gastrointestinal disorders | Romidepsin | 39 | 131 | |
| other | Diarrhoea | Gastrointestinal disorders | Romidepsin | 46 | 131 | |
| other | Dyspepsia | Gastrointestinal disorders | Romidepsin | 12 | 131 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Romidepsin | 9 | 131 |
| Total, other adverse events | Romidepsin | 124 | 131 |
| Total, serious adverse events | Romidepsin | 62 | 131 |
Source ClinicalTrials.gov
Papers7
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 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/NCT00426764
GET https://conductscience.org/api/trials/v1/NCT00426764/results?page=2